Senior Manager, Quality Compliance, External Manufacturing

Bristol Myers Squibb UK & Ireland; Dublin; On-site; EUR 100,000 - 150,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Job summary

Bristol Myers Squibb UK & Ireland is seeking a Senior Manager, ExM Quality Compliance to lead continuous improvement and compliance for External Manufacturing networks. You will own quality systems, prepare senior management for investigations, and ensure cGMP regulatory alignment across the USA, EU, and other markets.

The role requires 8–10+ years in pharma, a science degree, and strong leadership with experience audits, CAPA, change control, and working with CMOs.

Qualifications

• 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.

Responsibilities

• 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).
• Lead the BMS Fact Finding Information Team (FIT) and FIRM processes for major investigations involving ExM manufacture and present information to senior management.
• Support the Product Action Committee (PAC) process for recalls associated with CMOs managed by ExM.
• Provide quality/compliance support to the Quality Operations Managers.
• Raise Notifications to Management (NTMs) for major and critical investigations.
• Review and approve responses to Health Authority observations prepared by CMOs to ensure regulatory alignment.
• Write and/or review SOPs and other controlled documents to ensure compliance with BMS standards and cGMP requirements.
• Represent ExM on global quality teams and cross‑functional projects with SME input.

Skills

Quality compliance

Regulatory affairs

cGMP

Project management

Audits

Communication

Leadership

Education

BSc or equivalent in a scientific discipline

Tools

Change control

CAPA

Deviations

SOPs

Job description

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.

Specific Responsibilities Of This Role

• 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.
• Lead the BMS Fact Finding Information Team (FIT) and Fact-Finding Information Review Meeting (FIRM) processes for major investigations involving ExM manufacture. Prepare and present the information to senior management in support of the FIT / FIRM processes.
• 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.
• Provide quality/compliance support to the Quality Operations Managers.
• 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.

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 gaol 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 elevate compliance risks to senior management.
• 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.

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

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 [e-mail]. 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.

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 this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607108 Senior Manager, Quality Compliance, External Manufacturing