QA R&D - GMP Specialist (Investigational Medicinal Products)

The Quality Assurance R&D - GMP Specialist for Investigational Medicinal Products is responsible for ensuring compliance with GMP regulations and regulatory authority requirements throughout the IMP lifecycle. The role provides QA oversight of investigational products and Combination Products/Medical Devices, ensuring consistent quality, compliance, and data integrity. The Specialist will manage and oversee outsourced activities, deviation investigations, and change controls, and provide continuous training to staff on GMP requirements and best practices.

Requirements

• Degree in a scientific discipline (Pharmacy, Chemistry, Biotechnology, CTF or equivalent)
• Minimum 5 years of experience in Quality Assurance within a GMP-regulated environment
• Strong knowledge of GMP requirements (including EU GMP Annex 13), ICH Q8/Q9/Q10 guidelines, and familiarity with Combination Product/Medical Device regulations

Benefits

• Competitive salary
• Benefits package
• Opportunity for professional growth and development