Senior Manager, PV Process Quality Lead

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.

Position Summary
The Patient Safety group is responsible for ensuring the safety of our medicines. The Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

The Patient Safety Quality Management (SQM) organization supports shaping tomorrow's healthcare landscape through forward-thinking third party and internal compliance, transformative quality & procedural initiatives, PSMF excellence, facilitating engagement with PV Regulatory Intelligence, and dynamic external collaborations.

Duties/Responsibilities

- Shapes and directs strategic assessment, investigation, and closure of high-impact GVP deviations, influencing remediation priorities and organizational risk management.
- Leads advanced trending and root cause analysis, providing critical intelligence and persuasive recommendations to senior leadership for proactive compliance and quality improvements.
- Authorizes and refines QMS documentation, influencing policy standards for deviation management, management notification, and CAPA processes to ensure global regulatory compliance.
- Champions influential cross-functional partnerships with R&D and BMS stakeholders, driving company-wide adoption of robust GVP deviation and CAPA management practices.
- Acts as a senior authority for global Deviations and CAPA networks, influencing enterprise-wide processes and IT systems to meet and exceed GVP regulatory requirements.
- Drives engagement and alignment with GVP processes throughout Research & Development, serving as a key influencer in building a culture of quality and continuous improvement.
- Develops and leads impactful training initiatives, elevating team expertise on quality events and deviation investigations, and ensuring readiness for audits and inspections.
- Ensures accuracy and strategic use of deviation and CAPA data in the Pharmacovigilance System Master File (PSMF); proactively escalates and resolves complex issues with executive influence.
- Directs strategic updates and enhancements for assigned PSMF sections and annexes, ensuring consistency, readiness, and global alignment.
- Oversees and influences enhancements to the PV intelligence repository, driving system optimization to support evolving regulatory and business needs.
- Leads PV projects and initiatives within Safety & Quality Management (SQM), delivering strategic impact and organizational excellence.

Qualifications

Education/Experience/Licenses/Certifications:

- University degree in health or life sciences, or nursing qualification (preferred).
- Minimum 5 years’ experience in the pharmaceutical industry, including at least 2–3 years in Pharmacovigilance or a closely related field (e.g., Regulatory Affairs, Clinical, Medical Information).
- Proven leadership experience in quality management, compliance, audit, or quality control within the pharmaceutical sector.
- Demonstrated experience managing or leading cross-functional teams and strategic projects.

Specific Knowledge, Skills, Abilities:

- Proven ability to lead deviation investigations and CAPA development utilizing systematic, process-driven methodologies; expert in root cause analysis tools and techniques (e.g., Five Why’s, Is/Is Not, cause-and-effect diagrams).
- Advanced oral and written communication skills, with capability to deliver persuasive recommendati