Duties/Responsibilities

- Oversees, leads and directs strategic assessment, investigation, and closure of high-impact GVP deviations, influencing remediation priorities and organizational risk management decisions at a senior leadership level.
- Drives strategic projects and oversees process enhancements related to Deviations, Audit CAPA Management, and GVP Quality Risk Management, ensuring full alignment with global regulatory requirements and BMS quality standards.
- Develops and leads advanced trending and root cause analysis (including Fishbone, Five Why s, Is/Is Not methodologies), providing critical intelligence and persuasive recommendations to senior leadership for proactive compliance and quality improvements.
- Manages the GVP Risk Register; leads annual risk assessments and drives enterprise-wide QRM activities, including systematic identification, assessment, control, communication, and periodic review of pharmacovigilance quality risks.
- Collaborates with pharmacovigilance product medical leads, global process owners, subject matter experts, and third-party contract/process owners to ensure cross-functional coordination of risk assessments throughout the full product lifecycle, from first-in-human to global market withdrawal.
- During identification of potential third parties and external partners (vendors, distributors, business partners, development partners), assists with technical assessment as part of due diligence to determine quality, compliance capabilities, and health of the Quality Management System.
- Maintains and refines QMS documentation, influencing policy standards for deviation management, management notification, CAPA processes, and QRM to ensure global regulatory compliance.
- Champions cross-functional partnerships with R&D;, External Affairs, and BMS stakeholders, driving company-wide adoption of robust GVP deviation, CAPA, and QRM practices.




- Serves as Local Process Owner for GVP Quality Risk Management, providing vision and strategy; networks with all GxP Local Process Owners to create interdependencies and data sharing to identify quality risks across Patient Safety.
- Leads the reporting of Audit CAPA, GVP Quality Risk Management, and quality events/deviations at the Pharmacovigilance Safety Quality Forum ensuring senior PS leadership senior-level decision-making support and alignment.
- Develops and leads impactful training initiatives, elevating organizational expertise on deviation investigations, QRM, and CAPA, ensuring readiness for audits and health authority inspections.
- Ensures accuracy and strategic use of deviation, CAPA, and QRM data in the Pharmacovigilance System Master File (PSMF); proactively identifies and resolves complex issues with executive influence.
- Supports GVP Inspections (Health Authorities and Business Partners) in close collaboration with PV Quality and Compliance functions.

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In office Protocol

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Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Manager, PV Quality Risk Management & Deviations (Hyderabad)
🏢 Bristol-Myers Squibb
📍 Hyderabad