Qualified Person Als Quality Operations Group Lead Compliance (m/w/d)
Merck & Co., Inc.
Unterschleißheim, Germany
Not specified; not specified; not specified
Qualified person qualification eu 2019/6
Gmp compliance in sterile manufacturing
Batch release authority responsibilities
The role combines operational hands-on tasks with strategic leadership to ensure global product quality and patient safety
Job Summary
The role combines operational hands-on tasks with strategic leadership to ensure global product quality and patient safety.
Candidates will lead a team of seven while managing critical GMP compliance, batch releases, and site representation within a global network.
The position requires a qualified person with deep expertise in sterile pharmaceutical manufacturing and a commitment to high visibility on the shop floor.
Matching Summary
The role combines operational hands-on tasks with strategic leadership to ensure global product quality and patient safety.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Qualified Person qualification EU 2019/6
GMP compliance in sterile manufacturing
Batch release authority responsibilities
Team leadership of Quality Operations
Deviation management and complaint handling
Nice-to-have
Experience with aseptic validation processes
Strategic quality system development skills
Proactive problem-solving approach
International network collaboration experience
Key Requirements
Qualified Person certification per EU Regulation 2019/6
Degree in Chemistry, Pharmacy, or Biotechnology
Multi-year experience in pharmaceutical industry GMP