Associate Director, Qualified Person (QP) - Global Release

Biopharma Careers

Cruiserath

On-site

EUR 120,000 - 150,000

Full time

14 days+

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Job summary

Bristol Myers Squibb is seeking an Associate Director, Qualified Person (QP) to oversee FDP certification for EU/EEA and ROW markets. The role requires leadership of QP operations, ensuring regulatory compliance and effective product disposition across multiple manufacturing sites.

The candidate will act as the QP subject matter expert, guide risk-based decisions, and manage a team of quality professionals while coordinating with Regulatory, Manufacturing and Supply Chain to support launches and

Qualifications

Educated to a degree level in science, engineering or related discipline with extensive experience in biopharmaceuticals.
Qualified Person eligibility in the EU with minimum 5 years acting as QP on Manufacturer’s Authorisations.

Responsibilities

Certify finished product batches for EU/EEA and ROW in compliance with EU GMP and MA requirements.
Act as QP primary contact for product/brand questions and cross-functional projects.
Lead QP oversight and governance, ensuring product quality and regulatory compliance across sites.
Mentor QP team and other quality professionals, coaching and performance management.
Prepare for regulatory inspections and audits, demonstrating QP accountability.