Senior Manager, Quality Compliance, External Manufacturing

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

The Role

Bristol Myers Squibb is looking to recruit a Senior Manager, Quality Compliance, External Manufacturing on a 12 month fixed term contract.

Position Summary

The Senior Manager, Quality Compliance provides quality compliance oversight for pharma (intermediates, API and drug product/finished goods), and biologics CMOs within External Manufacturing. The position also drives effective implementation and continuous improvement of Quality Systems’ compliance across the Global External Manufacturing network. In addition, the role provides comprehensive quality and compliance support to Quality operations, Alliance Partners, Third-Party Customers/Contractors (TPCs/TPMs), and Marketing Authorization Holders (MAHs) to ensure BMS Good Manufacturing Practices (GMP) and regulatory standards are consistently met. The Senior Manager is also responsible for effective implementation of Quality Systems across Global External Manufacturing.

Duties / Responsibilities

Quality Compliance

• Lead Continuous Improvement and/or Compliance projects supporting the External Manufacturing (ExM) or network.
• Serve as Local Process Owner with responsibility for assigned Quality Systems (e.g., Change Control, Deviations, CAPA, Complaints), ensuring procedures, training, metrics, and compliance are maintained.
• Serve as Lead Site Change Champion with responsibility for manufacturing launches and high complexity CMO technical transfer projects.
• Lead the BMS Fact Finding Information Team (FIT) and Fact-Finding Information Review Meeting (FIRM) processes for major investigations involving ExM manufacture.
• Support the Product Action Committee (PAC) process for all recalls associated with CMOs managed by ExM.
• Support issuance of HA notifications (e.g. Field Alert Reports) where required.
• Raise Notifications to Management (NTMs) for major and critical investigations where required.
• Review and approve responses to Health Authority (HA) observations prepared by CMOs to ensure regulatory alignment.
• Write and/or review Standard Operating Procedures (SOPs) and other controlled documents to ensure compliance with BMS standards and cGMP requirements.
• Represent ExM on global quality teams, initiatives, and cross-functional projects, providing quality/compliance subject matter expertise.

Leadership & Process Ownership

• Where applicable, lead and develop direct reports; build a high-performance team culture and strong cross-functional relationships.
• Own all elements of the process including relevant procedures/forms, training materials, share point content, and metrics where applicable.
• Be primary subject matter expert for review of regulatory or directive changes.
• Regularly review the process for effectiveness and escalate compliance risks to senior management.
• Serve as the subject matter expert in audits / inspections.
• Develop and implement pro-active continuous improvement plans for the process.
• Support Annual Product Reviews/APQRs, vendor approvals, bona fides, and stability protocol updates, where applicable.

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.

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs. 

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.