About the Role
At Bristol Myers Squibb, we are committed to transforming patients’ lives through science. Our Patient Safety Quality Management (SQM) team sits at the heart of that mission — ensuring our pharmacovigilance systems are world‑class, inspection‑ready, and continuously improving. We are looking for a seasoned quality and compliance leader to drive strategic GVP deviation management, CAPA oversight, and quality risk management across a global, matrixed organization.
What You Will Do
- Lead the strategic investigation and closure of high‑impact GVP deviations, shaping remediation priorities and organizational risk management at a senior level.
- Drive enterprise‑wide CAPA management and quality risk initiatives, ensuring full alignment with global regulatory requirements.
- Deliver advanced root cause analyses and trend intelligence, translating complex data into persuasive recommendations for senior leadership.
- Maintain and evolve QMS documentation, setting policy standards for deviation management, management notification, and CAPA processes.
- Build and champion cross‑functional partnerships across R&D and BMS, embedding a consistent culture of quality and continuous improvement.
- Serve as the internal authority for global Deviations and CAPA networks, influencing enterprise IT systems and processes to meet GVP requirements.
- Lead the Pharmacovigilance Safety Quality Forum, reporting quality events, audit CAPAs, and risk management findings to senior Patient Safety leadership.
- Oversee the accuracy and strategic use of deviation and CAPA data within the Pharmacovigilance System Master File (PSMF).
- Monitor external intelligence — regulations, guidance documents, Health Authority inspection reports — ensuring risks are reviewed, escalated, and actioned appropriately.
- Design and deliver impactful training programs that sharpen team expertise and maintain audit and inspection readiness.
- Support GVP inspections in close collaboration with the PV Quality function.
Education and Experience
- University degree in health or life sciences, or a nursing qualification (preferred).
- 10+ years in the pharmaceutical industry, with at least 5 years in Pharmacovigilance or a related discipline (Regulatory Affairs, Clinical, Medical Information).
- Minimum 3 years of hands‑on experience in GVP Deviation and/or Inspection Management.
- Proven track record leading quality management, compliance, or audit functions within pharma.
- Demonstrated success managing cross‑functional teams and delivering complex strategic projects.
Skills and Capabilities
- Expert‑level proficiency in deviation investigation and CAPA development, including root cause analysis methodologies (Five Whys, Is/Is Not, cause‑and‑effect analysis).
- Exceptional communication skills — able to distil complex compliance data into clear, compelling narratives for senior stakeholders.
- Strong influencing and negotiation abilities, with sound judgment on escalation and conflict resolution.
- Highly organized with the ability to manage multiple high‑priority workstreams under stringent timelines, including inspection readiness activities.
- Proficient in pharmacovigilance tools, corporate QMS platforms, document management systems (SharePoint), and Microsoft Office Suite.
- Deep knowledge of global pharmacovigilance regulations and the ability to serve as an internal subject matter authority.
- Proactive mindset for identifying process improvement opportunities and driving efficiency across the Patient Safety organization.
Additional Information
- Travel: Approximately 10–25%, including overnight travel.
Equal Employment Opportunity Statement
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Bristol Myers Squibb is Disability Confident – Employer.
Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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.
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