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 at 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.
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.
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.
Qualifications, Knowledge And Skills Required
BSc or equivalent in a 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 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.
Additional Information
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.
Occasional travel may be required as part of this role.
Legal, EEO and Accessibility Information
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, direct inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo‑accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider 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 for this position, please visit https://careers.bms.com/california‑residents/ for additional information.
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.
R1602647 Manager, Quality Compliance, External Manufacturing
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