Manager* IMP Manufacturing QA
Job description
Join our team as a Manager* IMP Manufacturing QA and play a vital role in ensuring quality for our clinical trial programs. You will oversee quality throughout the supply chain and represent our QA function within dedicated clinical programs.
Requirements:
University degree in a technical/scientific field (Chemistry, Pharmacy, Biology, etc.)
Work experience in quality assurance or oversight, ideally in biotech/pharmaceuticals.
Experience working with CMOs/CDMOs.
Strong knowledge of EU GMP and FDA regulations for clinical manufacturing.
High accuracy, conscientiousness, and detail-oriented approach.
Excellent communication skills in English, with German fluency a plus.
Work conditions:
Competitive salary and benefits package.
Opportunity to contribute to groundbreaking medical advancements.
One-year contract position.
Responsibilities:
Represent QA for specific clinical programs, collaborating with core and sub-teams.
Oversee quality throughout the supply chain for clinical trials.
Monitor and manage quality events like change controls and deviations.
Review documents and provide QA approval for batch production.
Act as on-site QA representative at manufacturing partners (as needed).
About company
0-20 employees
Worldwide