Experience building and scaling quality organizations
The role involves leading the European Quality organization to ensure alignment with global strategies during the transition from clinical to commercial operations
Job Summary
The role involves leading the European Quality organization to ensure alignment with global strategies during the transition from clinical to commercial operations.
Candidates will serve as the primary interface with European regulatory authorities like the EMA and manage inspection readiness across the region.
The position requires establishing an effective EU Quality Management System compliant with EU GMP, GDP, GCP, and ICH guidelines.
Matching Summary
The role involves leading the European Quality organization to ensure alignment with global strategies during the transition from clinical to commercial operations.
Skills & Requirements
Must-have
20+ years GxP Quality experience
Deep knowledge of EU GMP/GDP regulations
Experience building and scaling Quality organizations
Leadership in regional or global teams
Expertise in EMA and national agency interactions
Nice-to-have
Biotech industry experience
Proactive quality culture leadership
Cross-functional collaboration skills
Strategic transition from clinical to commercial
Key Requirements
Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred)
Minimum 20 years of GxP Quality experience within the pharmaceutical industry
Track record of working in a GMP/GDP regulated environment