2,041 Director Of Safety jobs in the United States
Director, Safety Scientist
Posted 1 day ago
Job Viewed
Job Description
The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are important capabilities for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.
**Essential Functions of the Job:**
**Signal and Safety Data Evaluation**
+ Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile.
+ Define data acquisition strategy, methodology, and approach for safety evaluations.
+ Perform analysis of safety data and lead authoring of safety assessment
+ Drive collaboration with PSLs, Safety Scientists, Pharmacoepidemiologists, and cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy.
+ Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team
+ Lead the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
+ Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions.
+ Apply effective communication skills to lead and facilitate safety team meetings and drive decision making.
+ Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner.
+ Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Healthcare Professional communications (DHCP letter or DHPC), Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members.
+ Lead signal assessment documentation following BeiGene signal management and safety governance framework.
**Clinical Trial Support**
+ Lead the review of safety data and monitor the safety of patients on allocated clinical trials.
+ Lead the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees.
+ Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members.
+ Lead the authoring of Storyboards and Briefing Books for HA interactions.
+ Support ad-hoc review of the Safety Management Plans.
+ Lead Safety Science specific investigator training.
+ Risk Assessment, Regulatory Inquiries, and Periodic Reporting.
+ Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug. Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety.
+ Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs).
+ Lead and demonstrate ability to resource, plan, and fulfill additional evaluation requests with quality from health authorities (e.g., PRAC PSUSA) for assigned compounds.
+ Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents or safety section of clinical or regulatory documents.
+ Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs.
**Author Health Hazard Evaluations**
+ Contribute to integrated Benefit/Risk assessments.
**Promote and Advance the Field of Pharmacovigilance**
+ Responsible for effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies).
+ Contribute to continuous employee development programs, such as mentoring, coaching, and peer-to-peer learning.
+ Contribute to and provide Safety Science training to support team development.
+ Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity.
+ Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity.
+ Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations.
+ Execute any other tasks assigned by manager to assist in departmental activities.
**Supervisory Responsibilities:**
+ This position may have direct reports depending on the program / portfolio being led. The Director, Safety Scientist provides key support as an experienced safety scientist that leads and performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely with the Safety Science group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations and provides a high degree of support to assigned compounds and line manager.
**Computer Skills:**
+ Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information.
+ Advanced knowledge of MedDRA and signal management system
+ Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)
+ Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI
**Other Qualifications:**
+ Prior matrix management team experience
+ Clinical knowledge of various disease states, drug effects, human physiology and pharmacology
+ Demonstrated ability to prioritize and manage multiple deliverables simultaneously.
+ Demonstrated leadership, organizational and administrative skills.
+ Prior experience with Regulatory Agency interactions
+ Pharmaceutical product development experience, including individual study design and filing plans.
+ Experienced in global regulatory requirements for pharmacovigilance.
**Education Required:**
+ PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
+ MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring. 4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine and 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred
**Travel:** Less than 10%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Director, Safety Scientist
Posted 1 day ago
Job Viewed
Job Description
The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are important capabilities for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.
**Essential Functions of the Job:**
**Signal and Safety Data Evaluation**
+ Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile.
+ Define data acquisition strategy, methodology, and approach for safety evaluations.
+ Perform analysis of safety data and lead authoring of safety assessment
+ Drive collaboration with PSLs, Safety Scientists, Pharmacoepidemiologists, and cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy.
+ Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team
+ Lead the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
+ Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions.
+ Apply effective communication skills to lead and facilitate safety team meetings and drive decision making.
+ Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner.
+ Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Healthcare Professional communications (DHCP letter or DHPC), Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members.
+ Lead signal assessment documentation following BeiGene signal management and safety governance framework.
**Clinical Trial Support**
+ Lead the review of safety data and monitor the safety of patients on allocated clinical trials.
+ Lead the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees.
+ Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members.
+ Lead the authoring of Storyboards and Briefing Books for HA interactions.
+ Support ad-hoc review of the Safety Management Plans.
+ Lead Safety Science specific investigator training.
+ Risk Assessment, Regulatory Inquiries, and Periodic Reporting.
+ Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug. Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety.
+ Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs).
+ Lead and demonstrate ability to resource, plan, and fulfill additional evaluation requests with quality from health authorities (e.g., PRAC PSUSA) for assigned compounds.
+ Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents or safety section of clinical or regulatory documents.
+ Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs.
**Author Health Hazard Evaluations**
+ Contribute to integrated Benefit/Risk assessments.
**Promote and Advance the Field of Pharmacovigilance**
+ Responsible for effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies).
+ Contribute to continuous employee development programs, such as mentoring, coaching, and peer-to-peer learning.
+ Contribute to and provide Safety Science training to support team development.
+ Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity.
+ Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity.
+ Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations.
+ Execute any other tasks assigned by manager to assist in departmental activities.
**Supervisory Responsibilities:**
+ This position may have direct reports depending on the program / portfolio being led. The Director, Safety Scientist provides key support as an experienced safety scientist that leads and performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely with the Safety Science group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations and provides a high degree of support to assigned compounds and line manager.
**Computer Skills:**
+ Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information.
+ Advanced knowledge of MedDRA and signal management system
+ Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)
+ Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI
**Other Qualifications:**
+ Prior matrix management team experience
+ Clinical knowledge of various disease states, drug effects, human physiology and pharmacology
+ Demonstrated ability to prioritize and manage multiple deliverables simultaneously.
+ Demonstrated leadership, organizational and administrative skills.
+ Prior experience with Regulatory Agency interactions
+ Pharmaceutical product development experience, including individual study design and filing plans.
+ Experienced in global regulatory requirements for pharmacovigilance.
**Education Required:**
+ PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
+ MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring. 4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine and 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred
**Travel:** Less than 10%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Director, Safety Scientist
Posted 1 day ago
Job Viewed
Job Description
The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are important capabilities for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.
**Essential Functions of the Job:**
**Signal and Safety Data Evaluation**
+ Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile.
+ Define data acquisition strategy, methodology, and approach for safety evaluations.
+ Perform analysis of safety data and lead authoring of safety assessment
+ Drive collaboration with PSLs, Safety Scientists, Pharmacoepidemiologists, and cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy.
+ Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team
+ Lead the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
+ Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions.
+ Apply effective communication skills to lead and facilitate safety team meetings and drive decision making.
+ Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner.
+ Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Healthcare Professional communications (DHCP letter or DHPC), Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members.
+ Lead signal assessment documentation following BeiGene signal management and safety governance framework.
**Clinical Trial Support**
+ Lead the review of safety data and monitor the safety of patients on allocated clinical trials.
+ Lead the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees.
+ Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members.
+ Lead the authoring of Storyboards and Briefing Books for HA interactions.
+ Support ad-hoc review of the Safety Management Plans.
+ Lead Safety Science specific investigator training.
+ Risk Assessment, Regulatory Inquiries, and Periodic Reporting.
+ Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug. Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety.
+ Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs).
+ Lead and demonstrate ability to resource, plan, and fulfill additional evaluation requests with quality from health authorities (e.g., PRAC PSUSA) for assigned compounds.
+ Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents or safety section of clinical or regulatory documents.
+ Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs.
**Author Health Hazard Evaluations**
+ Contribute to integrated Benefit/Risk assessments.
**Promote and Advance the Field of Pharmacovigilance**
+ Responsible for effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies).
+ Contribute to continuous employee development programs, such as mentoring, coaching, and peer-to-peer learning.
+ Contribute to and provide Safety Science training to support team development.
+ Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity.
+ Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity.
+ Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations.
+ Execute any other tasks assigned by manager to assist in departmental activities.
**Supervisory Responsibilities:**
+ This position may have direct reports depending on the program / portfolio being led. The Director, Safety Scientist provides key support as an experienced safety scientist that leads and performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely with the Safety Science group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations and provides a high degree of support to assigned compounds and line manager.
**Computer Skills:**
+ Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information.
+ Advanced knowledge of MedDRA and signal management system
+ Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)
+ Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI
**Other Qualifications:**
+ Prior matrix management team experience
+ Clinical knowledge of various disease states, drug effects, human physiology and pharmacology
+ Demonstrated ability to prioritize and manage multiple deliverables simultaneously.
+ Demonstrated leadership, organizational and administrative skills.
+ Prior experience with Regulatory Agency interactions
+ Pharmaceutical product development experience, including individual study design and filing plans.
+ Experienced in global regulatory requirements for pharmacovigilance.
**Education Required:**
+ PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
+ MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring. 4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine and 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred
**Travel:** Less than 10%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Director, Safety Scientist
Posted 1 day ago
Job Viewed
Job Description
The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are important capabilities for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.
**Essential Functions of the Job:**
**Signal and Safety Data Evaluation**
+ Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile.
+ Define data acquisition strategy, methodology, and approach for safety evaluations.
+ Perform analysis of safety data and lead authoring of safety assessment
+ Drive collaboration with PSLs, Safety Scientists, Pharmacoepidemiologists, and cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy.
+ Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team
+ Lead the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
+ Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions.
+ Apply effective communication skills to lead and facilitate safety team meetings and drive decision making.
+ Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner.
+ Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Healthcare Professional communications (DHCP letter or DHPC), Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members.
+ Lead signal assessment documentation following BeiGene signal management and safety governance framework.
**Clinical Trial Support**
+ Lead the review of safety data and monitor the safety of patients on allocated clinical trials.
+ Lead the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees.
+ Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members.
+ Lead the authoring of Storyboards and Briefing Books for HA interactions.
+ Support ad-hoc review of the Safety Management Plans.
+ Lead Safety Science specific investigator training.
+ Risk Assessment, Regulatory Inquiries, and Periodic Reporting.
+ Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug. Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety.
+ Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs).
+ Lead and demonstrate ability to resource, plan, and fulfill additional evaluation requests with quality from health authorities (e.g., PRAC PSUSA) for assigned compounds.
+ Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents or safety section of clinical or regulatory documents.
+ Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs.
**Author Health Hazard Evaluations**
+ Contribute to integrated Benefit/Risk assessments.
**Promote and Advance the Field of Pharmacovigilance**
+ Responsible for effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies).
+ Contribute to continuous employee development programs, such as mentoring, coaching, and peer-to-peer learning.
+ Contribute to and provide Safety Science training to support team development.
+ Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity.
+ Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity.
+ Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations.
+ Execute any other tasks assigned by manager to assist in departmental activities.
**Supervisory Responsibilities:**
+ This position may have direct reports depending on the program / portfolio being led. The Director, Safety Scientist provides key support as an experienced safety scientist that leads and performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely with the Safety Science group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations and provides a high degree of support to assigned compounds and line manager.
**Computer Skills:**
+ Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information.
+ Advanced knowledge of MedDRA and signal management system
+ Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)
+ Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI
**Other Qualifications:**
+ Prior matrix management team experience
+ Clinical knowledge of various disease states, drug effects, human physiology and pharmacology
+ Demonstrated ability to prioritize and manage multiple deliverables simultaneously.
+ Demonstrated leadership, organizational and administrative skills.
+ Prior experience with Regulatory Agency interactions
+ Pharmaceutical product development experience, including individual study design and filing plans.
+ Experienced in global regulatory requirements for pharmacovigilance.
**Education Required:**
+ PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
+ MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring. 4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine and 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred
**Travel:** Less than 10%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Director Safety & Health

Posted 7 days ago
Job Viewed
Job Description
Please note the job posting will close on the day before the posting end date.
**Job Summary**
Responsible for the strategic direction and coordination of safety and health programs and functions throughout AEP. This includes development and implementation of policies, programs, and procedures in compliance with federal and state laws and regulations: accident prevention programs, Occupational Safety and Health Administration (OSHA) recordkeeping, safety awards program, safety and health training programs, employee health programs, and public and contractor safety programs. Maintain close liaison with applicable regulatory agencies, Company Regulatory Affairs, Environmental, Corporate Communications, and Risk Management.
**Job Description**
**What You'll Do:**
+ Direct the AEP Safety and Health Recognition Program, the maintenance of injury frequency and severity rates, as well as vehicle accident summaries for all Business Units.
+ Oversee industrial hygiene effectiveness reviews throughout the Company, review the results of such reviews, and implementation of recommended corrective measures.
+ Review standards promulgated by OSHA, DOT, MSHA, EPA, and NIOSH in order to evaluate the effects of proposed federal and state standards on Company operations and coordinate with appropriate personnel and AEP affiliations such as Edison Electric Institute.
+ Direct analysis, surveys, and inspections for the purpose of improving hazard control and determining the degree of compliance with federal, state, and local occupational safety and health regulations.
+ Direct the maintenance of the AEP Safety and Health Manual, including revisions, to include new processes, methods, and operations.
+ Direct the preparation of reports reflecting Company accident and injury experiences and keep abreast of all reporting standards.
+ Oversee the preparation and implementation of safety and industrial hygiene training programs and development of priority plans for federal and state health regulatory compliance.
+ Direct hazard analyses, occupational health studies, and specialized safety and toxic material surveys throughout the Company.
+ Direct the work and level of interaction relating to health-related issues with the consulting physician along with advising on corporate policies and procedures.
+ Lead the conduct of periodic safety and health audits throughout the Company, prepare reports of such audits, and discuss the results with management.
+ May act as a client manager to a group, as assigned.
**What We're Looking For:**
Education:
+ Bachelor's degree in safety, business administration, industrial hygiene, or engineering or equivalent work experience.
Work Experience:
+ Minimum of twelve years of safety experience in industry, preferably on a project level and with significant experience in organizing, initiating, conducting safety training, and maintaining safety and health programs.
+ Required License(s)/Certification(s): Maintain valid driver's license.
**Other Must Haves:**
+ Certification as Certified Safety Professional (CSP) and/or Industrial Hygiene (Certified Industrial Hygienist) desirable.
+ Thorough working knowledge of the federal safety and health laws (OSHA and MSHA) and related standards in construction, maritime, and general industry.
+ Strong working knowledge of industrial hygiene, AMSI, ASTM and NFPA standards and NEC code as applicable to the electric utility industry. Ability to develop and administer priority plans for safety and health regulation compliance.
+ Accountable, along with others, for developing methodology's that will reduce/eliminate events that cause injuries and illnesses to AEP employees, the public, or damage to equipment.
+ Company results will be favorably affected by proper adherence to and interpretation of the legal requirements regarding the federal and state occupational safety and health laws that will avoid or minimize legal action and fines; effective management support of improved safety and health performance and behaviors as an organizational core value will result in our achieving Zero Harm.
+ Position requires persistent, dedicated effort to keep abreast of constantly changing regulations. The incumbent must be the Company expert on laws and regulations relevant to safety and health which pertain to the electric utility industry. Must assume a leadership role for the Safety & Health effort throughout the Company and work with all Business Units in terms of implementation of a continually expanding Safety and Health Program.
+ Ability to formulate and coordinate safety and health programs and proposals at all levels of management within the system and employing skill in preparation, presentation and method of approach where a high degree of tact and persuasion is necessary.
+ Overnight travel is required.
**Where You'll Work:**
+ On-Site in APCO Headquarters in Charleston, WV
**Compensation Package:**
+ Base salary
+ Executive incentive compensation consisting of annual cash bonus and stock units
+ Comprehensive benefits package: medical, dental, vision, 401K matching, AEP pension,
Where Putting the Customer First Powers Everything We Do!
At AEP, we're more than just an energy company - we're a team of dedicated professionals committed to delivering safe, reliable, and innovative energy solutions. Guided by our mission to put the customer first, we strive to exceed expectations by listening, responding, and continuously improving the way we serve our communities. If you're passionate about making a meaningful impact and being part of a forward-thinking organization, this is the company for you!
#LI-ONSITE
#AEPCareers
**Compensation Data**
**Compensation Grade:**
SP20-011
**Compensation Range:**
$155, ,490.50 USD
The Physical Demand Level for this job is: S - Sedentary Work: Exerting up to 10 pounds of force occasionally (Occasionally: activity or condition exists up to 1/3 of the time) and/or a negligible amount of force frequently. (Frequently: activity or condition exists from 1/3 to 2/3 of the time) to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
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It is hereby reaffirmed that it is the policy of American Electric Power (AEP) to provide Equal Employment Opportunity in all respects of the employer-employee relationship including recruiting, hiring, upgrading and promotion, conditions and privileges of employment, company sponsored training programs, educational assistance, social and recreational programs, compensation, benefits, transfers, discipline, layoffs and termination of employment to all employees and applicants without discrimination because of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, veteran or military status, disability, genetic information, or any other basis prohibited by applicable law. When required by law, we might record certain information or applicants for employment may be invited to voluntarily disclose protected characteristics.
Director of Safety & Compliance
Posted today
Job Viewed
Job Description
Job Description
The Director of Safety & Compliance will provide leadership, direction and subject matter expertise for transportation safety and compliance (including driver minimum qualification standards, driver qualification files, DOT drug and alcohol program, transportation safety methods, training courses etc.). The Director coordinates with senior leadership in crafting short- and long-term strategies in building a culture of safety within the organization. The Director introduces and oversees systems and activities to maintain oversight of regulatory compliance status; provides training and professional development for management and drivers; coordinates and manages the crash management process; conducts audits and inspections of the transportation safety management process and monitors and reports metrics and indices reflecting performance. The Safety Director must be able to effectively lead and persuade others and possess excellent communications skills. They will oversee DOT & OSHA compliance, equipment, and facilities including training of personnel, driver e-log comprehension, accident management, and facilities review.
Background Required:
•Minimum 5 years of DOT transportation safety leadership (tanker preferred)
•Minimum fleet size (150+ tractors)
•Safety & environmental regulations (OSHA, DOT, FMCSA) (federal, state, & local)
•Electronic driver log administration and compliance
•Active & follow through Incident management
•Analyzation and independent resolution of a variety of difficult situations and problems using timely decision making
•Internal safety audits•Creation & management of transportation safety programs
•Accident/injury prevention & investigations
•Computer literate: Microsoft Word, Excel, PowerPoint, & Outlook
•Travel: 25%
•Location: Flowood, MS
Background Preferred (but not required):
•Certified Director of Safety (NATMI, NASP)
•Driver recruiting & retention
•Participant in state & national safety organizations
•Claims prevention
Other essential abilities and skills:
•Be involved in Corporate decision making processes that may exceed the Safety department
•Strong leadership skills•Excellent oral and written communication
•Data and analytically driven
•Ability to motivate, develop, and manage employees at all levels
•Able to be "on-call" on a rotational basis for after hours incident management
Job Posted by ApplicantPro
Assistant Director, Safety & Security

Posted 16 days ago
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The Assistant Director, Safety & Security supports and assists in providing leadership, guidance, and implementation of regional security operations and emergency preparedness and management for the safety and security of all tenants, vendors, visitors and the protection of assets. With direction from the Director, Safety & Security and in partnership with the regional management team, this role manages and administers policies, procedures and technical standards related to security and emergency operations, while ensuring delivery of services, staffing, utilization of technology, and policies and procedures are prudent, cost effective and compliant with federal, state and local laws and regulations.
Essential Functions:
Operations and Planning:
+ Oversee security operations and collaborate with uniformed security service provider leadership to ensure compliance with all administrative and contractual requirements and all applicable policies, procedures, rules, and regulations.
+ Review incident and activity reports to identify trends or direct corrective/preventative action.
+ Interface extensively with regional management staff to ensure adequate and effective service levels are being provided and that tenant security and safety concerns are addressed. Research and analyze problems and concerns regarding security and safety issues. Respond to inquiries and recommend appropriate action.
+ Maintain and update Emergency Preparedness and Management Plans in compliance with applicable laws. Assist in the coordination of developing and executing the regional Business Continuity Plan.
+ Assist with managing overall operating and capital budgets regarding security and emergency preparedness and management. Provide support of the annual security operating budget and re-forecasts at the property level.
+ Coordinate periodic inspections, incident after action reviews, and assessments of existing security and emergency preparedness programs. Identify and recommend improvement opportunities or enhancements. Perform feasibility and cost benefit analyses.
+ Collaborate with regional leadership on projects and events and coordinate security and emergency preparedness support and assistance.
Technology and Integrated Systems:
+ Coordinate installation, maintenance and operation of existing security and emergency systems and related software with external service provider vendor teams, Information Systems teams, and on-site security, and property management teams.
+ Collaborate with Development, Construction, Information Systems teams, and on-site security and property management teams for the design, specification, and implementation of integrated systems for new development projects, building improvement opportunities, and property re-positioning.
+ Assist with researching and conducting cost benefit feasibility studies of new and innovative technology, products, and procedures for potential future implementation. Identify existing systems integrations for potential upgrade, replacement, or efficiency improvement opportunities.
Training, Awareness and Community Relations:
+ Interface extensively with tenant management on all matters relating to security and emergency preparedness and management, focusing on quality service delivery and client satisfaction.
+ Coordinate and facilitate security and emergency operations seminars and awareness programs, and tabletop and readiness exercises for regional management staff, on-site service providers, and tenants. Coordinate mutual integration of building emergency plans with tenant business continuity plans.
+ Maintain ongoing relationships and collaborate regularly with local business community security/emergency management leadership and local, state, and federal law enforcement, public safety and emergency response officials for mutual information sharing.
+ Maintain up-to-date knowledge of security and emergency preparedness and management principles, practices, technology, and design, as well as applicable laws and regulations. Consult with security and emergency management colleagues, law enforcement and fire safety agencies, and industry vendors to discuss industry-wide approaches to common issues.
+ Participate in security, emergency management, and commercial real estate local associations' related meetings and events.
Requirements and Qualifications:
+ BA/BS in business administration, criminal justice or related field and/or comparable experience in security/safety management positions, preferred.
+ A minimum of 5 -10 years experience in asset protection and loss prevention.
+ Physical Security Professional (PSP) or Certified Emergency Manager (CEM) desirable.
+ Commercial Real Estate (CRE) experience preferred.
+ In-depth knowledge of security/safety principles, standards, operations, and technology.
+ Excellent written and oral communication skills.
+ Proven initiative and the ability to create program timetables and execute them.
+ Ability to work independently, as well as part of a team.
+ Excellent analytical and project management skills.
+ Demonstrated skills for organization and multi-task prioritization.
+ Ability to coordinate work efficiently, set priorities and motivate others.
+ Effective problem solving skills.
+ Ability to work in a fast paced environment and adaptability to changing demands.
+ Ability to provide quality customer service and excellent client/tenant relations.
+ Proficiency with Microsoft Office Applications.
+ Flexibility with being on-call around-the-clock (24x7) and working nights and weekends as needed for special events or responding to emergencies.
+ Certified Protection Professional (CPP) desirable.
+ Solid understanding of the Life Safety Code, OSHA regulations, and other basic security/safety principles, standards, operations and technology.
Physical Requirements:
+ Involves work of a general office nature usually performed sitting such as operation of a computer.
+ Involves work of a general office nature usually performed standing such as operation of a fax and printer.
+ Involves work such as tours throughout property portfolio usually performed by walking and by climbing stairs.
+ Involves movement between departments to facilitate work.
+ Involves potentially stressful situations in responding to and mitigating emergency situations, as well as being exposed to adverse environmental conditions, such as severe weather, fumes, smoke, airborne particles, or caustic chemicals.
+ This is an on-site position and requires in-person attendance.
Internal and External Contacts:
+ Regularly interfaces both verbally and in writing with tenant contacts, leasing, construction, development, and financial teams as well as external vendors, construction professionals, consultants, public safety officials, and with the general public.
Reporting Structure:
+ This position reports to the Director, Safety & Security who provides supervision, guidance and evaluates work performance on a periodic basis.
Salary Range:
$108,500 - $146,000. BXP offers a competitive total rewards package including base salary and annual discretionary bonus. The range represents expected base salary; compensation will be determined based on role, skills, experience, qualifications, location, and other job-related factors. Our comprehensive benefits include medical and dental coverage, a retirement savings plan with competitive company match, backup childcare, educational assistance, employee support programs, a generous commuter transit subsidy and more.
BXP is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
Boston Properties is an Affirmative Action and Equal Opportunity Employer. We are committed to fair and impartial treatment in all of our relations with employees, as well as applicants for employment, to recruit, upgrade, train, and promote in all job titles without regard to race, color, gender, gender identity or expression, sexual orientation, religion, age, national origin, disability, marital status, protected veteran status, genetic information or any other legally protected characteristic.
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RETAIL DIRECTOR & SAFETY OFFICER
Posted today
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JOB SUMMARY: Provides overall leadership to Retail Store, Purchasing, and Rental Departments. Responsible for establishing and maintaining guest services, oversee operation of Retail Store and Rental, ensuring maximum sales and profitability through merchandise, inventory, expense control, staff management, and managing budgeted operating costs. Safety Committee oversight.
DUTIES & RESPONSIBILITIES:
• Responsible for recruitment of Retail Store and Rental team in conjunction with established policies & procedures, controlling payroll expenses.
• Perform all necessary management functions to effectively and efficiently manage team; provide guidance, leadership and coaching.
o Ensure staff compliance with all company policies & procedures; manage, document and report employee issues, counsel staff; facilitate staff disciplinary actions, up to and including termination, with guidance from HR and following established policies & procedures.
• Coordinate the review of team performance annually, with input from CSM. Set appropriate goals for team members; follow-up as required.
• Maintain and analyze Retail Store and Rental financial data. Coordinate next actions upon review with President and Controller.
• Follow month-end close procedures on schedule.
• Strive to keep Retail Store and Rental inventory at acceptable levels; control Retail Store shrink.
• Look for ways to continuously improve Retail Store, Rental, and team efficiencies, and lead per Core Values.
• Attend executive committee meetings; confer with executive personnel to review achievements and discuss required changes in goals or objectives resulting from current status and conditions.
• Facilitate regular team meetings; participate in daily, weekly, monthly or annual planning process as appropriate; participate in communicating and
administering company policies and procedures, directing and coordinating departmental activities to develop and implement long-range goals and objectives to meet business and profitability growth objectives.
• Work with Controller to maintain product costs and margins, determine how the financial and key metrics information can help them improve business performance
• Model integrity and good leadership in day-to-day activities; maintain good communication and collaboration with colleagues and other leaders within the Company.
• Effectively lead Retail Facility safety systems and procedures by providing knowledge and expertise in compliance with key governmental regulations including OSHA and other state and local regulations; lead Retail Facility Safety Committee; ensure compliance with relevant safety and health regulations; ensure annual training compliance; plan and implement the safety policies and procedures; ensure confidentiality at all levels; coordinate facilitation of routine inspection of Retail Facility.
• Collaborate as needed on investigations of accidents, injuries, and near misses.
• Serve as Manager on Duty in management rotation, including bi-weekly Saturday availability.
• Other duties as assigned.
• Regular attendance is an essential function of this position.
SKILLS & QUALIFICATIONS:
1. HS Diploma or equivalent, advance training or schooling, preferred.
2. Strong retail management and inventory control experience with minimum 5 years’ experience in supervisory/ strategic retail role.
3. Experience creating and working within a budget.
4. Possess excellent verbal, written, inter-personal and customer-facing communication skills.
5. Possess strong leadership skills with ability to promote and facilitate teamwork.
6. Excellent computer skills, with proven experience in MS Office required. Epicor software experience preferred.
7. Possess strong problem-solving skills and adept at making decisions.
8. Ability to resolve conflicts in a positive and constructive manner.
9. Knowledge of OSHA regulations and industry best practices; prior experience overseeing safety and possession of current safety certifications, preferred.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. This position is active and requires standing, walking, bending, kneeling, stooping, crouching and twisting. Requires use of general office equipment to include computer monitors and keyboard. May occasionally lift or move items over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision.
Compensation based upon experience. Competitive benefits offered include health insurance with health savings account, dental, vision, life and disability insurances, 401k with match, Paid Time Off, paid holidays, McFarlanes’ Retail Service Center employee discount, EAP, company events, and more! To be considered for this opportunity, please apply by sending resume to: HR at McFarlane Mfg. Co., P.O. Box 100, Sauk City, WI 53583 or email resume to
recblid qyk52838jvh00qxk9qqjhy06swexnqMcFarlane's
Director, Safety and Health-Tulsa

Posted 7 days ago
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Job Description
Are you being referred by a ONE Gas employee? If so, reach out to that connection and ask about the employee referral program. They can send you a link to apply directly so they can receive credit!
**Job Posting End Date:** This posting will be removed on **October 10th, 2025.**
**Role Summary:**
You will report to the VP of Environmental, Health, Safety, and Technical Training and will be based in Tulsa, OK. You will have 10+ years of Safety/Environmental and leadership experience. You will have a Bachelor's Degree in Safety, Environmental, or Engineering. A Certified Safety Professional Designation is strongly preferred, along with a working knowledge of Human and Organizational Performance. You will collaborate closely with internal stakeholders across the ONE Gas footprint as well as manage relationships with external service providers.
**What You Will Do**
Provides leadership and oversight to the Safety and Health functions for ONE Gas.
Manage and provide direction for the following corporate and governmental Safety and Health programs:
+ Contractor safety - ISNetworld
+ DOT drivers
+ Operations calling system
+ Crisis Management Plan
+ Corporate security
+ Emergency response
+ Voluntary protection
+ Driver and fleet safety
+ Axiom
+ SHAVR
+ Corporate metrics
Develop, analyze, and implement ideas and opportunities that support the continuous improvement of the Safety & Health performance of the corporation.
Interact with all levels of management to ensure identified Safety and Health goals and objectives are met and administered.
Act as a liaison with agencies, trade associations, etc. as an advocate for ONE Gas in respect to proposed Safety & Health laws and regulations.
Serve as an active member on the Environmental Safety and Health (ESH) Leadership Committee representing the Safety & Health functions of the corporation and the Safety and Health team.
Supervise and guide employees by providing direction and support as required.
Maintain, revise, update and/or prepare corporate Safety and Health policies and procedures as required.
Analyze, review, monitor, and/or prepare reports and information including but not limited to:
+ Statistics & trend data
+ Metrics including ESH goals"SHAVR" (Safety Health & Vehicle Reports)
+ Incident investigation reports
+ Safety & Health auditing
Regular and reliable attendance is required in performance of job.
Employee may be required to perform additional duties as assigned.
**What You Will Need**
Preferred Bachelor's Degree Safety & Health, Engineering, or other related field with previous job-related experience or an equivalent combination of formal education and job-related experience.
Experience and thorough knowledge of Safety & Health laws, regulations, procedures, and programs.
Experience with and thorough knowledge of:
+ Oil and natural gas operations and distribution systems
+ Industrial hygiene
+ DOT vehicle transportation
+ Crisis, risk, and process safety management
+ Voluntary protection programs
+ Driver and fleet safety programs
Experience with application of basic math, algebra, and statistical formulas.
Experience in use and function of office equipment including computers and applicable software.
Experience reading and interpreting policies, procedures, trend data, reports, safety manuals, correspondence, and governmental regulations.
Experience composing, compiling, and preparing reports, policies, procedures and correspondence applicable to position.
Experience interacting, advising, and communicating effectively.
Demonstrated ability to lead, direct and/or supervise.
Experience developing information and preparing presentations.
Demonstrated ability to read and write fluently in English.
Minimum Applicable driver's license.
Requires travel to company offices and job sites.
Preferred Certified Safety Professional
Preferred Ability to obtain Department of Homeland Security (DHS) clearance.
Mobility to travel in office surroundings and around job sites out-of-doors.
Ability to effectively communicate with all levels of management, staff, and employees.
Ability to conduct oral presentations as required.Visual abilities sufficient to perform job duties.
**Diversity at ONE Gas**
Inclusion & Diversity is so important to us that we made it one of our core values, values that guide and direct our actions as we go about our daily business. We know that every employee makes a difference and contributes to our success through their unique talents and abilities. We also acknowledge that we can accomplish great things by listening and learning from each other.
**ONE Gas has great benefits! Here are just a few:**
+ Medical/Dental/Vision packages that fit your family's needs.
+ Paid Time Off
+ 401K that is 100% matched up to 6%.
+ Profit Sharing Plan
+ Paid Parental Leave
+ Basic and Optional Employee Term Life Insurance
+ Education Assistance and Tuition Reimbursement
**Position Requirements:**
The job description is not intended to be a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of One Gas. Where positions are covered by a collective bargaining unit agreement, the terms and conditions of the agreement will apply.
ONE Gas, Inc., and its divisions will provide equal employment opportunity for qualified persons without regard to sex, race, religion, color, national origin, ethnicity, age, sexual orientation, gender identity or expression, disability, military status or genetic information.
Job ID: 6635
Functional Area: Safety
Position Type: Full-Time Regular
Relocation Provided: Yes
Location: Tulsa, OK
Department: SAFETY
Internal / External: Internal and External
Experience Required: More than 10 years
Executive Director Safety and Quality
Posted today
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Job Description
Job Description
Description:
Description:
As the Executive Quality and Safety Director for Blake’s Beverage Company, you will be responsible for overseeing and driving a common quality process across our three hard cider production facilities as well as the production facility of our sweet cider business. You will ensure that our products meet or exceed the highest standards for quality, safety, and regulatory compliance while aligning with the brand's commitment to craftsmanship and innovation. This leadership role requires a hands-on approach to developing, implementing, and refining quality control processes, managing teams, and ensuring that every one of our products meets the expectations of our consumers.
In addition, the candidate will also be responsible for implementing a safety focused culture where “all accidents are preventable”.
You will work closely with the operations, production, and supply chain teams to implement best practices in quality management and continuous improvement. In addition, you will be instrumental in fostering a culture of safety and quality, continuous improvement, providing training, and upholding industry certifications and standards.
The Executive Quality Director will oversee all quality activities related to the design and manufacture of all new products. The director will report to the VP of Operations, for the hard cider division. The plant quality managers will report directly to the corporate executive quality director.
The Quality Director is expected to be the impartial voice of the customer. The person in this position will have the authority to stop production and product launches as required due to major quality issues and not meeting customer requirements.
The Quality Director will be responsible for all aspects of corporate quality including product design, product launches and manufacturing quality.
It is expected that the use of modern quality management principles based on a built-in-quality philosophy of Do Not Accept / Build / Ship a Defect will be utilized and implemented.
For the EHS portion of the position the candidate will ensure safety Compliance by prioritizing the safety of our employees by enforcing strict adherence to safety protocols and regulations and fostering a culture of safety awareness.
Requirements:Key Responsibilities:
· Company Culture: Establish a company culture which focuses on safety as the number one operating priority and that "ALL ACCIDENTS ARE PREVENTABLE".
Establish a company culture which focuses on a Do Not Accept / Build /
Ship a Defect quality mind-set.
· Quality Staff: Establish a lean and focused quality staff which in turn leads the
quality process for the company.
· Quality Management System: Lead the development, implementation,
and maintenance of the company’s National Quality Management System
(QMS), ensuring consistency across all production sites.
· Product Quality Assurance: Oversee the entire product lifecycle from
raw material sourcing to final product release, ensuring products meet all
internal and external quality standards and regulations.
· Team Leadership: Lead a national team of quality assurance managers
and technicians across multiple facilities. Provide training, mentorship,
and guidance to ensure adherence to best practices and quality
standards.
· Regulatory Compliance: Ensure that all products meet required federal,
state, and local regulations, including food safety, labeling, and alcohol
industry-specific standards. Work closely with legal and compliance teams
to stay ahead of industry changes.
· Continuous Improvement: Establish a culture of rapid response and structured root cause analysis for quality issues, (at both Blake’s Orchard & Cider Mill and Blake’s Beverage Company). Lead the teams in transitioning away from assumption-based problem solving by instilling a disciplined 8D or equivalent approach to identifying and validating true root causes.
Drive continuous improvement initiatives related to product quality, process
efficiency, and cost reduction. Develop and monitor key performance indicators
(KPIs) to track and improve product consistency and quality.
· Supplier & Vendor Management: Collaborate with sourcing and procurement teams to ensure that raw materials and ingredients meet stringent quality standards. Manage supplier quality audits and establish quality agreements where necessary.
· Consumer Experience: Partner with marketing, sales, and customer service teams to address any quality-related concerns or product issues raised by customers, ensuring brand consistency and consumer satisfaction.
· Data Analysis & Reporting: Analyze quality control data and produce reports for upper management to provide insights on product quality trends, and areas of improvement, and to drive strategic decision-making.
· Innovation: Work closely with R&D and product development teams to support new product launches, ensuring they meet quality standards from concept through commercialization.
· Environmental Health & Safety (EHS): Lead and implement EHS programs to ensure a safe working environment across all facilities, with a focus on preventing accidents, reducing workplace risks, and adhering to environmental standards.
· Field Product Issues & Recalls: Oversee the identification, investigation, and resolution of any product quality issues that arise in the field, ensuring that appropriate corrective actions are implemented swiftly.
· Common processes: Drive common processes and systems across the organization.
· KPIs: Develop plant quality performance metrics and associated performance targets.
· Built-In-Quality: Lead the implementation of the Built-In-Quality principle as included in a Lean Manufacturing System.
· Problem Solving: Develop and implement a disciplined, structured and standardized problem solving process in support of resolving quality issues.
· Advanced Problem Solving: Lead the development of advanced problem solving sources such as Shainin Red X / Statistical Engineering, etc.
· Feedback / Feedforward: Capture closed loop learning / best practices so as to be implemented into company future activities / processes / product programs.
· Business Plan Deployment: Lead the quality business planning process for the company.
· Quality Management: Establish a modern and effective quality management system (QMS) that will be utilized across the organization to document quality processes.
· Lead the company’s EHS initiatives
Qualifications:
· Education: Bachelor’s degree in Food Science, Engineering, Chemistry, or related field. A Master's degree or industry certifications (e.g., Six Sigma, ISO 9001, HACCP) is a plus.
· Experience: 10+ years in quality assurance or quality control in the beverage or food industry, with at least 3 years in a leadership role.
- At least 3 years as a plant quality manager.
- At least 2 years as a corporate quality director
- At least 3 years of experience in running manufacturing operations such
as a plant manager, assistant plant manager or area manager.
· Leadership Skills: Proven ability to lead, motivate, and develop cross-functional teams. Experience managing teams across multiple locations is a plus.
Ability to instill a sense of urgency and analytical discipline across teams,
elevating the quality mindset from reactive to proactive.
· Technical Expertise: Strong knowledge of quality control processes, tools, and techniques, including statistical process control (SPC), root cause analysis, and corrective actions. Experience with quality management software is advantageous.
· Regulatory Knowledge: Familiarity with food safety regulations (FDA, USDA), alcohol industry standards (TTB, state alcohol control boards), and other relevant safety and compliance standards.
· Communication Skills: Strong verbal and written communication skills, with the ability to interact with employees at all levels of the organization, suppliers, and external stakeholders.