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 recommendations and quality improvements to diverse internal and external stakeholders.
- Strong influential and negotiation skills for resolving complex compliance issues and driving consensus among senior stakeholders.
- Strong organizational acumen for managing multiple high-priority deliverables, stakeholders, and stringent timelines.
- Ability to distill and clearly communicate strategic concepts, data, and operational updates to senior leadership and cross-functional teams.
- Advanced collaborative problem-solving, data flow analysis, and operational support using digital tools and technology platforms.
- Proactive risk identification and process impact assessment, with demonstrated escalation and mitigation according to established protocols.
- Competent in collecting, analyzing, and reporting complex PV data using advanced pharmacovigilance tools.
- Proficient in record management and reporting within structured, electronic formats, ensuring data integrity and compliance.

Advanced expertise in the following:

- Microsoft Office Suite.
- Corporate Safety Database.
- Corporate Quality Management System (QMS).

Travel Required (nature and frequency): Approximately 10%-25% travel, including overnight, may be required in this position.

#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.

Warsaw - PL: zł227,340 - zł275,484

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

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.

R1600003 : Senior Manager, PV Process Quality Lead