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/life-at-bms/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 [adastaffingsupport@bms.com](mailto:adastaffingsupport@bms.com). 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