5,846 Quality Management Systems jobs in the United States

Working Location: CALIFORNIA, SAN JOSE Workplace Flexibility: Onsite For more than 100 years,Olympus has focused on making peoples lives healthier, safer and more fulfilling. Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives. Our fiveCore Valuesempower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus . Job Description Manage staff responsible for the maintenance of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the maintenance and improvement of quality management systems at Olympus facilities in the U.S. manage and execute key Quality Projects. Job Duties Manage staff responsible for the maintenance of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the maintenance and improvement of quality management systems at Olympus facilities in the U.S. manage and execute key Quality Projects. Support current and future quality management system development. Work with management and technical personnel from various departments within Olympus to understand existing systems and processes for purposes of identifying and documenting the most efficient workflow sequence needed to support the development maintenance and improvement of quality management systems at Olympus facilities within the U.S. Oversee CAPA activities related to the San Josefacilities, including but not limited to, status monitoring reporting follow-up verification and closure activities. Support CAPA activities at other facilities within the U.S. as needed. Manage the backroom at routine and periodic audit and assessment activities at the San Jose facilities including internal and external audits and inspections required to ensure that QSR / ISO compliance is maintained at all levels of the organization. Support these activities at other Olympus locations as needed. Oversee special projects related to the development maintenance and improvement of Quality Management Systems and production or Quality Processes at Olympus facilities in the U.S. Perform all other essential duties as directed. Job Qualifications Required: 4-year Bachelor of Science degree Minimum of 5 years supervisory or management experience in a regulated medical industry (Medical Devices, Pharmaceuticals, Biologics). Minimum of 8 years' experience in Quality Assurance. Strong leadership skills / experience required. Quality System experience required. Experience effectively completing CAPAs and NCRs). Can teach Good Documentation practices. Strong knowledge of quality tools (Root Cause Analysis, Process Mapping). Periodic travel to other facilities to support quality initiatives or training. Preferred: Strongly prefer Lean or Six Sigma skills and experience (DMAIC). Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Caf, Fitness Center** Connected Culture you can embrace: Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance *US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefit and incentives . The anticipated base pay range for this full-time position working at this location is$124,873.00-$174,822.00/ year, plus potential for annual bonus (subject to plan eligibility and other requirements).Olympus considers a variety of factors when determining actual compensation for this positionincluding: level of experience, working location, and relevanteducation and certifications. At Olympus, we are committed to Our Purpose of making peoples lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . You Belong at Olympus We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1- ). Lets realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: | United States (US) | California (US-CA) | San Jose |Quality & Regulatory Affairs (QA/RA) #J-18808-Ljbffr

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

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. Position Overview The Sr. Manager, Quality Management Systems will play a key leadership role in the design, deployment, and continuous improvement of Immunome’s Quality Management System (QMS). Reporting to the Head of Quality Systems, this role will be responsible for ensuring the effective implementation and oversight of core quality system elements, including GxP document control, records management, and training administration. This position requires cross-functional collaboration and vendor oversight to support quality and regulatory compliance from early development through commercialization. Responsibilities Document Control & Records Management Serve as the process owner for GxP-controlled document and records management. Develop, implement, and maintain SOPs, templates, and controlled workflows in the electronic Document Management System (eDMS/eQMS). Ensure controlled documents (e.g., SOPs, policies, Quality Agreements) are current, reviewed periodically, and updated to reflect regulatory and business changes. Lead ongoing system optimization efforts to ensure scalability and usability of the document control platform. Provide quality oversight for manufacturing and quality records supporting GxP operations. GxP Training Program Administration Serve as the owner of GxP training processes and systems. Define and maintain training requirements and curricula for GxP personnel in collaboration with functional area leads. Develop and deliver training for system users and support integration of off-the-shelf content where applicable. Oversee assignment, tracking, and reporting of training compliance through the eQMS. Support development of training effectiveness strategies in collaboration with functional leads. Quality System Leadership & Oversight Contribute to the strategic direction of Immunome’s Quality Systems function. Identify and implement process improvements to enhance system efficiency and compliance. Define and monitor quality metrics and KPIs to measure the health of Document Control and Training programs. Support inspection readiness activities, including document retrieval and system demonstration during audits and regulatory inspections. Perform and lead continuous improvement initiatives to enhance the maturity and effectiveness of Immunome’s Quality Systems. Serve as SME during audits and regulatory inspections, including retrieval of GxP documents and training records. Support Quality Management Review with data on system performance, training compliance, and document lifecycle health. Collaborate with IT, Regulatory, Clinical, and Technical Operations teams to ensure QMS alignment across all GxP functions. Other Participate in the implementation and configuration of additional QMS modules as Immunome’s quality infrastructure evolves. Support other compliance and quality initiatives as assigned. Qualifications Bachelor’s degree in life sciences or equivalent A minimum of 7 years of experience in a regulated biotechnology or pharmaceutical company; minimum 3 years of primary experience in QMS and/or Document and Training Administration Excellent proficiency in Microsoft Applications, especially MS Word. Knowledge and Skills Proven experience in setting up and managing validated GxP Document Management and Training Systems, including oversight of vendor relationships. Proficiency with electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office applications (Word, Excel, PowerPoint). Expertise in designing, maintaining, and administering GxP training programs, with a strong interest in and ability to develop and/or deliver training content. In-depth knowledge of data integrity principles and their practical application in the management of EDMS/eQMS. Strong continuous improvement mindset with a proactive, solution-oriented approach to system optimization and process enhancement. Solid understanding of FDA, EMA, ICH, and other global regulatory requirements related to document control and training compliance. Experience supporting both clinical and commercial-stage programs, with a thorough understanding of the product lifecycle from development through commercialization. Excellent project management, organizational, and leadership skills, with the ability to multitask and manage priorities in a fast-paced, evolving environment. Outstanding verbal and written communication skills; able to influence and collaborate effectively across all levels and functions within the organization. Demonstrated success in leading or contributing to cross-functional initiatives, including the management of external vendors and service providers. Experience with biologics and ADCs is desirable; familiarity with small molecule operations is a plus. Washington State Pay Range $161,553 - $189,823 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Create a Job Alert Interested in building your career at Immunome, Inc? Get future opportunities sent straight to your email. Apply for this job * indicates a required field First Name * Last Name * Preferred First Name Email * Phone Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education Degree Select. Select. Select. Are you currently or have you ever been excluded or debarred by the OIG, DOJ, FDA, or any other Federal or State agency? * Select. Are you subject to a non-compete or other restrictive covenant with your current or former employer that bars you from employment at Immunome? * Select. Do you live within daily commuting distance of Bothell, WA or are you willing to relocate? * Yes, I live within daily commuting distance of Bothell, WA. Yes, I am willing to relocate. No, but I am willing to travel weekly. No, I do not live within daily commuting distance of Bothell, WA, I am not willing to relocate, and I am not willing to travel weekly. Will you now or in the future require the company to commence (“sponsor”) an immigration case to employ you (for example, H-1B or other employment-based immigration case)? This is sometimes called “sponsorship” for an employment-based visa status. * Yes, I will now, and in the future, require the company to commence (“sponsor”) an immigration case to employ me. No, I will not now, but yes in the future, require the company to commence (“sponsor”) an immigration case to employ me. No, I will not now, nor in the future, require the company to commence (“sponsor”) an immigration case to employ me. Are you authorized to work lawfully in the United States for the company? * Yes, I am authorized to work lawfully in the United States for the company. No, I am not authorized to work lawfully in the United States for the company. #J-18808-Ljbffr

• Assures compliance with all SOPs, cGMP, FDA, as well as all applicable company compliance guidelines, standards and objective

• Oversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab Event, Product Quality Complaints (PQCs), Corrective Action Preventive Actions (CAPAs) and Continuous Process Improvements (CPIs)

• Works directly and cross functionally throughout company (i.e., QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and overseeing and ensuring timely, accurate, effective and compliant investigation and resolution

• Reviews and approves laboratory (OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs

• Performs in-depth data analysis to identify compliance concerns, root causes and recommend/ implement improvements, including CAPAs and CPIs, across departments as appropriate

• Applies quality risk management principles in design (and resolution) of key quality management system elements to ensure compliance

• Tracks and trends deviations and product quality complaints

• Engages in activities to continuously assess/improve quality systems by identifying and proactively resolving quality issues

• Develops, analyzes and compiles quality metrics and highlights; Reports periodic quality metrics pertaining to investigations/CAPAs/CPIs and PQCs to Quality leadership and other appropriate company personnel

• Assists in training, including but not limited to: investigative processes, CAPAs and CPIs, etc.

• Participates in regulatory agency inspections and customer audits, as needed; Performs and/or participates in internal and external audits, as needed

• Manages, coaches and mentors direct reports

• Any other assignments determined by Quality management

• People management experience
• Strong hands-on knowledge of cGMPs in the pharmaceutical industry and application of current Good Documentation Practices (cGDPs) within pharmaceutical industry
• Experience implementing and managing quality systems and processes
• Familiar with US FDA guidance and other international guidelines on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
• Strong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective investigations
• Proficiency with Microsoft Office

• Certified Quality Manager, Engineer or Auditor
• Experience working with drug-device combination products (highly desirable)

Tris Pharma, Inc. ( is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively, timely and compliantly achieve quality goals and key performance metrics across multiple quality functions and systems including, but not limited to: investigations, deviations, Out-of-Specifications (OOS)/Out-of-Trend (OOT)/Lab Event, Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations, etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA, as well as all applicable company compliance guidelines, standards and objectiveOversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab Event, Product Quality Complaints (PQCs), Corrective Action Preventive Actions (CAPAs) and Continuous Process Improvements (CPIs)Works directly and cross functionally throughout company (i.e., QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and overseeing and ensuring timely, accurate, effective and compliant investigation and resolutionReviews and approves laboratory (OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs Performs in-depth data analysis to identify compliance concerns, root causes and recommend/ implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in design (and resolution) of key quality management system elements to ensure complianceTracks and trends deviations and product quality complaintsEngages in activities to continuously assess/improve quality systems by identifying and proactively resolving quality issues Develops, analyzes and compiles quality metrics and highlights; Reports periodic quality metrics pertaining to investigations/CAPAs/CPIs and PQCs to Quality leadership and other appropriate company personnelAssists in training, including but not limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits, as needed; Performs and/or participates in internal and external audits, as neededManages, coaches and mentors direct reportsAny other assignments determined by Quality managementRequirementsMinimum education and years of relevant work experience:Bachelors degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 3 of those years in a supervisory or manager role) Special knowledge or skills needed and/or licenses or certificates requiredPeople management experience Strong hands-on knowledge of cGMPs in the pharmaceutical industry and application of current Good Documentation Practices (cGDPs) within pharmaceutical industryExperience implementing and managing quality systems and processesFamiliar with US FDA guidance and other international guidelines on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionStrong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective investigations Proficiency with Microsoft OfficeSpecial knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager, Engineer or AuditorExperience working with drug-device combination products (highly desirable)Work Arrangements: 100% in office. Anticipated salary range: $120-160k/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans and women, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI