Quality Compliance Senior Manager

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Inspection Readiness & Risk Management

• Maintain permanent Audit readiness across ExM.

• Support self-inspections, internal audits, Health Authority inspections and/or Customer Audits at EXM sites as required.

• Lead or oversee self-inspection activities.

• Support the Policy Evaluation and Regulatory landscape (PEARL) program and Global Reg Observation evaluation (GROe).

• Provide quality oversight of CMOs (API, intermediates, biologics), including, Product Quality Complaints.

• Review/approve QMS documents and maintain controlled Document & Record Management systems.

• Represent ExM Quality on global or Local projects.

• Represent ExM during Health Authority inspections, including preparation activities and on-site support.

• Author responses to Health Authority inspection observations and review responses prepared by CMOs.

• Coordinate and track the annual CMO Risk Assessment (RA), ensuring timely completion.

• Support the development and monitoring of Quality Risk Mitigation Plans based on annual and interim RA triggers.

• Present risk, inspection, and audit trends, issues, and exceptions at ExM Quality Councils.

In addition, the Senior Manager, ExM Quality Compliance will:

• Where applicable, lead and develop direct reports; build a high-performance team culture and strong cross-functional relationships.

• Manage goal setting, performance, and development of team members where applicable.

• Own all elements of the process including relevant procedures/ forms, training materials, share point content, metrics where applicable

• Display technical knowledge of the process and understand risks/weaknesses in the system

• Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with BMS

policies/directives where applicable

• Responsible for ensuring the elements of the process are current and reflect current practices

• Be primary subject matter expert for review of regulatory or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the process

• Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, waste elimination) for their effectiveness and provide feedback to the Quality management team for action and

remediation

• Own relevant process issues – speak to trends/issues/exceptions at ExM Quality Councils

• Own Health Authority commitments related to the process

• Serve as the subject matter expert in audits / inspections

• Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance

• Review process performance, lead remediation where needed, and escalate compliance risks to senior management.

• Support Annual Product Reviews/APQRs, vendor approvals, bona fides, and stability protocol updates, where applicable.

Key Responsibilities:

• Supports and manages assignments to simplify and improve processes and systems.
• Understands and applies industry regulations knowledge to an understanding of the business operation to achieve regulatory compliance.
• Identifies any gaps in the quality management system (QMS) and takes necessary actions to correct and improve.
• Improves the efficiency of the quality management system (QMS) by managing simplification initiatives throughout the organization.
• Contributes to developing and upholding the company's quality systems and processes.
• Confirms that the quality management system (QMS) aligns with specific regulatory requirements.

Qualifications, Knowledge and Skills Required:

• BSc or equivalent in a scientific discipline such as Natural Sciences,

Chemistry, Microbiology, Biology, or Pharmacy.

• 8–10+ years’ experience in the pharmaceutical industry, preferably in

Quality, Manufacturing Technology, Regulatory Affairs, or within a Health

Authority agency.

• Extensive technical knowledge of chemical, biological, and/or

pharmaceutical operations with firsthand experience in manufacturing,

quality control, quality assurance, regulatory sciences, and R&D

interfaces.

• In-depth knowledge of cGMP and GDP regulations for the USA, EU, and

other international markets.

• Direct experience interacting with Health Authorities (e.g., FDA, EMA) and supporting or leading inspections.

• Direct experience working with external manufacturers and providing

quality oversight at CMO sites.

• Strong analytical and problem-solving skills.

• Strong negotiation, communication, presentation, and interpersonal skills. • Ability to build relationships and influence or enforce quality decisions at

internal and external sites.

• Strong project management capability.

• Ability to balance business requirements with scientific and quality

decision-making.

• Highly detail-oriented with strong organizational and follow-up skills.

• Ability to work independently with minimal supervision.

• Comfortable working in a fast-paced environment with dynamic timelines. • Ability to lead, coach, and motivate team members across geographically dispersed locations.

• Strong collaboration and facilitation skills across multiple functional

groups.

• Self-motivated with the ability to manage and prioritize multiple projects

simultaneously.

• Ability to achieve targets and adapt to changing business priorities.

• Strong presentation skills and confidence in public speaking.

• Travel requirement: typically approx. 10% but up to 25%, depending on

business need.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance 
  

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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