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

BMS ExM Quality Compliance-Quality Services is looking to recruit for a 12 month fixed term contract a Manager, Quality Services, to join the Global Quality External Manufacturing group based out of the BMS External Manufacturing Office (Plaza 254) in Dublin, Ireland or Boudry, Switzerland.

This role is focused on providing quality and compliance support to the Global Business unit, Quality Operations, Alliance Partners and Third Party Customers in External Manufacturing Quality. Ensuring that appropriate BMS GMP and regulatory standards are adhered to for products supplied by BMS sites and CMOs through External Manufacturing to Alliance Partners and Third-Party Customers (TPMs).

Key Responsibilities

• Provision of Quality Compliance support to the Global Operations teams.
• Oversight of Alliance Partners and Third-Party Customers.
• Preparation and oversight of Quality Agreements.
• Support for the Annual Product Review (APQR) process.
• Support for ExM, Enterprise and GBU Quality Council processes.
• Generation, compilation and reporting of metric data to support Global Quality Metric reporting.

This role requires close collaboration with various business units, Alliance Partners and Third-Party Customers (TPCs) to align with their priorities and objectives.

This role will report into the Associate Director, Quality Compliance, Global External Manufacturing Quality.

Key Duties and Responsibilities

• Support preparation, revision, and maintenance of Quality Agreements with CMOs, internal BMS sites, Third Party Customers, and Alliance Partners.

• Provide day-to-day Quality Services support to ExM Operations, including APQR coordination, Quality Agreement activities, and handling quality compliance queries.

• Support compliance tracking activities across the GBU.

• Support ExM, Enterprise, and GBU Quality Council activities by preparing inputs, ensuring metrics availability, and tracking action items.

• Assist in maintaining Quality Services systems (e.g., APQR, Quality Agreements, Quality Council processes) in alignment with procedures and training.

• Support management of relationships with Third Party Customers and Alliance Partners and coordinate quality-related communications such as deviations, change controls, and complaint responses.

• Support Regulatory, CMC, Supply Chain, and other cross-functional partners on filings, renewals, investigations, and product lifecycle activities.

• Compile and report Quality Services metrics and trend data and support continuous improvement activities related to QMS performance.

• Review or assist with review of QMS as assigned and support network-wide continuous improvement initiatives impacting QMS effectiveness, including contributing to GROe assessments.

• Serve as Local Process Owner, as required, with responsibility for assigned Quality Systems (e.g., APQR, Quality Council, Quality Agreements), ensuring procedures, training, metrics, and compliance are maintained.

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. 

Qualifications, Knowledge and Skills Required

• BSc or equivalent in scientific discipline
• Greater than five (5) years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a Health Authority agency
• Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations, including manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
• Direct experience interacting with Health Authorities and supporting inspections, specifically FDA and/or EMA
• Direct experience interacting with external manufacturers and supporting quality at external manufacturing sites
• In-depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
• Ability to assess the right balance between business targets and scientific and quality decisions
• Strong analytical and problem-solving skills
• Ability to build relationships, partnerships and influence and/or enforce quality decisions at external and internal sites as appropriate
• Good communication and organisational skills
• Project management skills

Occasional travel may be required as part of this role.

#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 adastaffingsupport@bms.com. 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 TAEnablement@bms.com. 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.

R1602647 : Manager, Quality Compliance, External Manufacturing