4,474 Director Of Quality jobs in the United States

**Director Quality Management/Improvement**
This role requires associates to be in-office 3 days per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. Alternate locations can be considered.
_Please note that per our policy on_ **_hybrid/virtual work_** _, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law._
The **Director Quality Management/Improvement** is responsible for developing, coordinating, communicating, and implementing a strategic quality management and improvement program for a state plan.
***Candidate** **MUST** **be domiciled and licensed in the state of Massachusetts***
**How will you make an impact:**
+ Develops, deploys and measures behavioral health strategic quality plan for statewide managed care contract and crisis line services.
+ Acts as the Quality subject matter expert (SME) supporting continuous quality improvement (CQI) and promotes broad understanding and collaboration across departments, and with external stakeholders.
+ Is accountable for development, measurement strategy and implementation of interventions that support Quality Improvement Activities.
+ Leads development of performance improvement plans and evaluation program.
+ Links strategic efforts with clinical and network to improve experience of care and services of members.
+ Oversees quality complaints and grievances and reporting to the state.
+ Leads audits of delegated services and oversees compliance activities to ensure regulatory and compliance standards are met.
+ Responsible for all KPIs in the contract related to Quality.
+ Leads Quality Measure Improvement Plan including HEDIS, Health Equity and other state defined quality measurement intervention program. This includes development of action plans, deployment of interventions and ongoing monitoring of performance. Responsible for overall improvement of incentive program based on measure improvement.
+ Supports the External Quality Review Organization (EQRO) reporting and state audit processes.
+ Provides leadership for QM representation in new business activities and acts as liaison between company and state partners.
+ Ensures compliance with National Committee for Quality Assurance (NCQA) behavioral health and health equity standards for managed care contract and compliance with American Association of Suicidology (AAS) and International Council of Helplines (ICH) accreditations for crisis line services.
+ Hires, trains, coaches, counsels, and evaluates performance of direct reports.
**Minimum Requirements:**
+ BA/BS in a health or business related field; 10 years of experience in a healthcare environment, including prior management experience; or any combination of education and experience, which would provide an equivalent background.
**Preferred Skills, Capabilities and Experiences:**
+ Extensive experience leading quality performance improvement, implementation, and program development to support accreditation including developing, implementing, monitoring and tracking performance of quality programs strongly preferred.
+ Current, active, unrestricted license in MSW, LMHC, APRN, or MFT strongly preferred.
+ Advanced knowledge of HEDIS interventions to include clinical intervention strongly preferred.
+ Robust capabilities to analyze data insights and strategically implement interventions to address and rectify situations when targets are not being met strongly preferred
+ CQM experience in a managed care organization preferred.
+ Population health management and/or clinical quality program development experience preferred.
+ 3-5 years of managing direct reports strongly preferred.
+ 5 years direct management of quality programs strongly preferred.
For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $135,520 to $212,520
Locations: Massachusetts
In addition to your salary, Elevance Health offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws _._
*The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, paid time off, stock, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health.
Who We Are
Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve.
How We Work
At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process.
The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws.
Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact for assistance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.

**Director Quality Management/Improvement**
This role requires associates to be in-office 3 days per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. Alternate locations can be considered.
_Please note that per our policy on_ **_hybrid/virtual work_** _, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law._
The **Director Quality Management/Improvement** is responsible for developing, coordinating, communicating, and implementing a strategic quality management and improvement program for a state plan.
***Candidate** **MUST** **be domiciled and licensed in the state of Massachusetts***
**How will you make an impact:**
+ Develops, deploys and measures behavioral health strategic quality plan for statewide managed care contract and crisis line services.
+ Acts as the Quality subject matter expert (SME) supporting continuous quality improvement (CQI) and promotes broad understanding and collaboration across departments, and with external stakeholders.
+ Is accountable for development, measurement strategy and implementation of interventions that support Quality Improvement Activities.
+ Leads development of performance improvement plans and evaluation program.
+ Links strategic efforts with clinical and network to improve experience of care and services of members.
+ Oversees quality complaints and grievances and reporting to the state.
+ Leads audits of delegated services and oversees compliance activities to ensure regulatory and compliance standards are met.
+ Responsible for all KPIs in the contract related to Quality.
+ Leads Quality Measure Improvement Plan including HEDIS, Health Equity and other state defined quality measurement intervention program. This includes development of action plans, deployment of interventions and ongoing monitoring of performance. Responsible for overall improvement of incentive program based on measure improvement.
+ Supports the External Quality Review Organization (EQRO) reporting and state audit processes.
+ Provides leadership for QM representation in new business activities and acts as liaison between company and state partners.
+ Ensures compliance with National Committee for Quality Assurance (NCQA) behavioral health and health equity standards for managed care contract and compliance with American Association of Suicidology (AAS) and International Council of Helplines (ICH) accreditations for crisis line services.
+ Hires, trains, coaches, counsels, and evaluates performance of direct reports.
**Minimum Requirements:**
+ BA/BS in a health or business related field; 10 years of experience in a healthcare environment, including prior management experience; or any combination of education and experience, which would provide an equivalent background.
**Preferred Skills, Capabilities and Experiences:**
+ Extensive experience leading quality performance improvement, implementation, and program development to support accreditation including developing, implementing, monitoring and tracking performance of quality programs strongly preferred.
+ Current, active, unrestricted license in MSW, LMHC, APRN, or MFT strongly preferred.
+ Advanced knowledge of HEDIS interventions to include clinical intervention strongly preferred.
+ Robust capabilities to analyze data insights and strategically implement interventions to address and rectify situations when targets are not being met strongly preferred
+ CQM experience in a managed care organization preferred.
+ Population health management and/or clinical quality program development experience preferred.
+ 3-5 years of managing direct reports strongly preferred.
+ 5 years direct management of quality programs strongly preferred.
For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $135,520 to $212,520
Locations: Massachusetts
In addition to your salary, Elevance Health offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws _._
*The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, paid time off, stock, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health.
Who We Are
Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve.
How We Work
At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process.
The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws.
Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact for assistance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Director, Quality Management Systems

Responsible for the design, implementation, continuous improvement, and oversight of robust Quality Management Systems (QMS) at the Elanco Fort Dodge site to support a risk-based quality culture in alignment with Elanco and industry standards. Monitors the health of the Elanco QMS at the Fort Dodge site and identifies cross-functional areas of opportunity or risk for action and reports to the appropriate quality governance.

Your Responsibilities:

• Leads Quality Management Systems (QMS):  Implements, maintains, and improves QMS processes, ensuring compliance with regulations and Elanco standards. Provides technical guidance and training to the QMS team. Oversees budgets, authors the Site Quality Plan, and drives continuous improvement initiatives.
• Manage Audits and Inspections:  Prepares for and manages regulatory inspections and corporate audits. Ensures inspection readiness, reviews QMS records, and drives timely completion of corrective actions.
• Provides Quality Governance:  Develops and implements governance processes (e.g., Quality Lead Team, Deviation Review Board). Identifies and analyzes quality risks, reporting the overall state of QMS control to senior leadership.
• Oversees Training and Development:  Develops and executes training programs for the Elanco QMS. Ensures training program effectiveness within the QMS department. Identifies professional development opportunities for self and team.
• Leads Investigations and CAPA:  Reviews and approvals of manufacturing and Quality department investigations, ensuring compliance, root cause identification, and effective corrective and preventative actions (CAPA).

What You Need to Succeed (minimum qualifications):  

• Education: Bachelor’s degree in science-related discipline.
• Experience: 10+ years’ experience in a regulated pharmaceutical/vaccine manufacturing environment.  5+ years of experience in people management including direct & indirect reports.
• Thorough knowledge of cGMP/GLP regulatory requirements for Biotech products, including direct experience with external audits (USDA, FDA, EMEA).
• Previous experience in department oversight (organizational, budgeting, strategy).

What will give you a competitive edge (preferred qualifications):  

• Advanced degree highly preferred
• Demonstrated proficiency in lean/5S/six sigma methodologies
• Ability to set up partnerships with regulatory authorities to resolve quality & compliance issues.
• Versatility in conflict resolution, problem solving and working with cross functional teams.
• Sound business acumen and strategic mindset

Additional Information:   

• Location: Fort Dodge, Iowa:  On-Site Work Environment – Excellent relocation package available!

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
**About the Site:**
Located just outside Atlanta, Takeda's state-of-the-art manufacturing facility in Covington is one of the largest biotech production sites in the world. As a pivotal part of Takeda's global manufacturing network, the Covington site plays a key strategic role in supplying high-quality plasma-derived therapies to patients worldwide. Equipped with advanced technology and modern processes, the facility supports ongoing innovation, helping to drive Takeda's growth and mission to deliver life-changing medicines.
**About the role**
As our Quality Control Leader, you will play a pivotal role in guiding and supporting all quality control activities at our site, encompassing analytical chemistry, microbiology, and adherence to laboratory best practices. Your work will be crucial in ensuring we meet high standards for product safety, compliance, and continuous improvement. You'll report directly to the Site Quality Head and be a visible champion of Takeda's Quality Culture.
**How you will contribute**
+ Lead and manage the Quality Control (QC) Laboratory, including the Analytical Chemistry and Microbiology teams.
+ Develop and uphold quality control processes to guarantee product safety and compliance.
+ Manage a QC team responsible for 24/7 testing of raw materials, intermediates, and finished products.
+ Ensure all operations meet internal and external (regulatory) quality standards and stay current with new requirements.
+ Hire, develop, and recognize technical staff; foster a culture of growth and acknowledgment.
+ Serve as a key advisor and handle technical issues and scheduling for the QC team.
+ Evaluate the effectiveness of quality control activities with site leadership.
+ Lead and drive continuous improvement initiatives focused on quality, reliability, and cost savings, including digital projects.
+ Manage the budget for the QC department.
+ Develop and maintain the site contamination control program with a focus on sterility assurance.
**What you bring to Takeda**
+ Bachelor's degree in science, engineering, or a related technical field (or equivalent experience).
+ At least 10 years of relevant experience, including 7+ years in a leadership role.
+ Strong background in managing large, multi-function laboratories and extensive experience in Analytical Chemistry.
+ Solid understanding of regulatory requirements (FDA, EMA, cGMP, GDDP).
+ Experience managing regulatory inspections and audit readiness.
+ Familiarity with laboratory testing for endotoxin and sterility (preferred).
+ Effective at managing budgets and team development.
+ Experience with digital and process improvement initiatives.
**Important Considerations**
Physical requirements, working conditions, and travel:
+ Work in a clean, controlled environment that requires special clothing (gowning, PPE).
+ Must not wear make-up, jewelry, contact lenses, nail polish, or artificial nails in manufacturing areas.
+ Be comfortable working in areas that may be cold, hot, or have confined spaces; clean room and variable storage conditions apply.
+ Ability to work multiple shifts, including weekends or overtime as needed.
+ Up to 10% travel may be required.
+ Potential exposure to chemicals and biological agents that require specific PPE.
**What Takeda can offer you:**
+ Comprehensive Healthcare: Medical, Dental, and Vision
+ Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
+ Health & Wellness programs, including on-site flu shots and health screenings
+ Generous paid time off for vacation, sick leave, and volunteering
+ Community Outreach Programs and company match of charitable contributions
+ Family Planning Support
+ Professional development and training opportunities
+ Tuition reimbursement
**More About Us:**
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ
#LI-LA1
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
USA - GA - Social Circle - Hwy 278
**U.S. Base Salary Range:**
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
USA - GA - Social Circle - Hwy 278
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes

**Director, Quality Control**
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.
The Director of Quality Control is responsible for all activities within the QC department. The QC team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation and Sample Management.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
**The Role**
+ Manage QC resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.'
+ Interact and communicate with customers to ensure expectations are established, agreed to, and achieved.
+ Engage actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.
+ Develop a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.
+ Accountable for all activities within the Quality Control department: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation, Sample Management as well as other functions (which include: technical data review, training, instrument maintenance, lead investigator, LIMS).
+ Effectively communicates Quality vision and expectations across site, including periodic site wide GMP training in addition to focused trainings.
+ Drives systemic process changes as a result of Deviations/Complaints and other quality trends.
+ Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan.
+ Other duties as assigned.
**The Candidate**
+ Doctorate Degree in STEM discipline with 8+ years related experience, OR Master's Degree in STEM discipline with 12+ years related experience, OR Bachelor's Degree in STEM discipline with 15+ years related experience.
+ 6+ years of leadership experience required.
+ Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
+ Understand the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
+ Ability to communicate complex technical information to non-technical audiences.
+ Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.
+ Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.
+ Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
**Why You Should Join Catalent**
+ Defined career path and annual performance review and feedback process
+ Diverse, inclusive culture
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
+ Dynamic, fast-paced work environment
+ Community engagement and green initiatives
+ Generous 401K match and Paid Time Off accrual
+ Medical, dental and vision benefits effective day one of employment
+ Tuition Reimbursement
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Director, Quality Control

The Director of Quality Control provides comprehensive administrative and technical direction across diverse QC functions, including Virology, Microbiology, and Immunochemistry. This pivotal role ensures timely and compliant support for all testing phases, setting departmental strategy and driving continuous improvement while adhering to internal specifications and regulatory requirements like USDA and cGMP/GLP. The Director champions strategic initiatives, manages significant budgets, and fosters cross-site collaboration within the Elanco network.

Your Responsibilities:

• Strategic Leadership: Lead and direct the Quality Control department, establishing strategic objectives, managing significant budgets, and developing a high-performing team to ensure efficient operations and data integrity.

• Regulatory Compliance: Ensure robust compliance with 9 CFR, USDA, cGMP/GLP, and Elanco Global Quality Standards across all QC operations, including documentation, change management, and laboratory investigations.

• Operational Oversight: Oversee all aspects of quality control testing, from raw materials to product release, ensuring timely data generation, thorough out-of-specification (OOS) investigations, and proactive risk mitigation.

• Continuous Improvement: Drive innovation and continuous improvement initiatives within QC, sharing best practices across the Elanco network and ensuring the validated state of test methods and laboratory systems.

• Technical Expertise: Offer expert technical guidance, troubleshooting, and scientific support to the team, developing and updating SOPs, and improving laboratory techniques and procedures.

What You Need to Succeed (minimum qualifications):

• Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or an advanced degree.

• 6 years of experience in a regulated pharmaceutical/vaccine manufacturing environment, with significant experience in Quality Control laboratory operations and personnel management.

• Proven experience in department oversight, including organizational, budgeting, and strategic planning. Demonstrated ability to lead teams to achieve results and actively engage in the leadership and professional development of team members.

What Will Give You the Competitive Edge (preferred qualifications):

• Significant working and theoretical knowledge to objectively assess procedures, apply appropriate risk assessment, and recommend improvements. Thorough and technically correct decision-making skills.

• Advanced oral and written communication skills, with the ability to work and communicate effectively with diverse groups across the organization at all levels, both locally and globally.

• Ability to use technical knowledge to solve complex problems, recognize and react to the significance of data/results, and lead investigations.

• Proficiency in lean/5S/six sigma methodologies.

Additional Information:   

• Location: Winslow, Maine:  On-Site Work Environment – Excellent relocation package available!

Don’t meet every single requirement?  Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!    

Elanco Benefits and Perks:   

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:  

• Multiple relocation packages  

• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)  

• 8-week parental leave  

• 9 Employee Resource Groups  

• Annual bonus offering  

• Flexible work arrangements  

• Up to 6% 401K matching 

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Quality Control Director  

This role provides administrative and technical leadership to Quality Control teams overseeing Virology, Immunochemistry, Microbiology, and other key areas. The Director will manage quality control operations, ensuring compliance with corporate and regulatory requirements while supporting internal departments and external customers.  

Your Responsibilities:   

• Provide quality oversight to the department and site regarding compliant documentation approaches involving change management, good documentation practices, sample control, laboratory systems and laboratory investigations. 

• Assist with audit responses and completion of assigned CAPAs by target due dates.  

• Develop and maintain standard operating procedures (SOP) and training for sample control and accountability. 

• Proactively identify and mitigate risks to quality control processes, ensure the ongoing maintenance and improvement of validated test methods, and implement improvements ensuring a high functioning and efficient laboratory.  

• Oversee quality control investigations by ensuring employee training, reviewing reports for compliance, and facilitating cross-functional root cause analysis and CAPA development. 

What You Need to Succeed (minimum qualifications):  

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals or a related field with 10 years of relevant experience.  

• At least 5 years' experience in people leadership. 

• Experience in a regulated pharmaceutical/vaccine manufacturing environment.

• Well versed in regulatory requirements, inclusive of cGMP/GLP. 

What Will Give You a Competitive Edge (preferred qualifications):  

• Ability to plan, schedule, organize, prioritize, and coordinate project activities. 

• Demonstrates proficiency in lean/5S/six sigma methodologies 

• Good knowledge of statistics, databases, and quality principles. 

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!    

Elanco Benefits and Perks:   

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:  

• Multiple relocation packages  

• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)  

• 8-week parental leave  

• 9 Employee Resource Groups  

• Annual bonus offering  

• Flexible work arrangements  

• Up to 6% 401K matching 

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
_Lilly is currently constructing an advanced manufacturing facility for production of APIs (small molecule and peptide) located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly's largest investment in manufacturing capacity and is intended to provide for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations._
**Main Purpose and Objectives:**
The Senior Director - Quality Control is part of the Senior Leadership Team of the Lilly Lebanon API site (LP1). The QC Senior Director provides administrative and technical leadership in the development, performance, and maintenance of the QC Labs throughout the start-up, implementation, and day-to-day operations of LP1.
The Sr. Dir. - QC must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The Sr. Dir. - QC will work cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.
In the project delivery and start-up phase of the LP1 site, the Sr. Dir. - QC will be flexible in supporting project delivery, building a new organization, developing and implementing the necessary systems and business processes required to support GMP operations, and building the site culture. This will require significant collaboration, creativity, and resilience as the site grows to a full-scale GMP manufacturing operation.
**Key Responsibilities:**
+ Provide technical leadership, performance management, training and development of staff
+ Maintain a safe work environment
+ Ensure GMP compliance
+ Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
+ Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
+ Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
+ Ensure adequate oversight and technical excellence for investigations and complaints
+ Collaborate with site team to develop the strategy for the technical agenda to improve process control, yield, efficiency and productivity for all products within the site portfolio
+ Provide oversight for technical projects to improve process control, capacity, yield, and quality
+ Ensure adequate technical representation and engagement within the site and network governance meetings to influence technical agendas
+ Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites
+ Engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization
**Minimum Requirements:**
+ Bachelor's Degree in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field
+ 10+ of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment
**Additional Preferences:**
+ Ability to influence and lead diverse groups
+ Experience with complex regulatory, business, or technical issues for pharmaceutical manufacturing
+ Strong analytical and quantitative problem-solving skills
+ Experience with Empower software
+ Experience with LIMS implementation and use within a manufacturing environment
+ Experience with statistical analysis of data
+ Technical leadership, administrative and organizational skills
+ Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
+ Demonstrated Project Management skills and ability to coordinate complex projects
+ Ability to communicate and influence effectively across functional groups and stakeholders
+ Strategic thinking and ability to balance short term needs with long term business evolution
+ Ability to build relationships with internal and external customers and partners
+ Enthusiasm for changes, team spirit and flexibility
+ Demonstrated ability to learn & apply technical/scientific knowledge
**Additional Information:**
+ Ability to travel (approximately 10-20%)
+ Onsite position
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly

Director, Quality Control Lab
Category: Quality
Position Type: Regular Full-Time
External ID: 18015
Location: Lake Forest, CA, United States
Date Posted: Oct 15, 2025
Hiring Range: 172,000.00 to 195,300.00 USD Annually
Share: share to e-mail Tweet share to twitter Share on Facebook share to facebook Share on LinkedIn share to linkedin
Apply Now
**Overview**
POSITION SUMMARY STATEMENT:
The Director, Quality Control Lab will be responsible for managing all laboratory functions in Quality Control and will work with and train chemists and technicians to operate laboratory equipment, implement test procedures and ensure compliance in the Herbalife laboratories.
DETAILED RESPONSIBILITIES/DUTIES:
+ Provides leadership, guidance and direction to QC lab to support the department's and company's strategic initiatives and goals.
+ Work with our industry partners and scientific affiliates and contribute to the advancement of analytical technologies and method research.
+ Implement innovation ideas and continuous improvement activities
+ Initiate investigations for non-conforming product and develop Corrective and Preventive program.
+ Liaise with the regulatory authorities on laboratory operations.
+ Responsible for applying inspection standards to products shipped directly from contract manufacturers to outside locations.
+ Develop and maintain a system that assures all certificates of analyses are reviewed against required finished product specifications as written in Agile PLM (Product Lifecycle Management).
+ Periodically perform a mock recall to assure that the systems have qualified and acceptable traceability standards.
+ Develop training program for scientists and lab technicians to ensure compliance with Good Laboratory Practices and current Good Manufacturing Practices.
+ Support regulatory audit preparation.
+ Perform additional duties as assigned.
+ Develop metrics and reports to assess performance, trend and analyze data and take appropriate actions as appropriate. Track, report and provide periodic reports to management in support of Quality Metrics. Leverage data to improve product quality and laboratory efficiency.
+ Lead laboratory operations and maintain the laboratories in compliance with ISO17025 accreditation requirements and other applicable local laws/regulations.
SUPERVISORY RESPONSIBILITIES:
Manages chemists, technicians, and laboratory supervisors.
**Qualifications**
REQUIRED QUALIFICATIONS:
Skills:
+ Strong leadership skills with expertise in implementing quality processes, systems and strategies
+ Proven understanding in laboratories operations
+ Expertise in ISO17025 requirements
+ Strong proven hands-on experience with variety of both GMP and GLP matters
+ Strong verbal and written communication skills with ability to work with a high degree of accuracy and detail
+ Strong interpersonal skills and the ability to work well as part of a team
Experience:
+ 10+ years of laboratory operations experience
Education:
+ Bachelor's degree in life sciences or equivalent technical field.
#LI-TK1!
At Herbalife, we value doing what's right. We are proud to be an equal opportunity employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected characteristic. We value diversity, strive for inclusivity, and believe the differences among our teammates is a key contributor to Herbalife's ongoing success.
Herbalife offers a variety of benefits to eligible employees in the U.S. (limited to the 50 States and the District of Columbia), which includes Group Health Programs, other Voluntary Benefit Programs, and Paid Time Off. Group Health Programs include Medical, Dental, Vision, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Basic Life/AD&D; Short-Term and Long-Term Disability and an Employee Assistance Program (EAP).
Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance. Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.
If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please email your request to

.
Share: share to e-mail Tweet share to twitter Share on Facebook share to facebook Share on LinkedIn share to linkedin