Qualified Person Als Quality Operations Group Lead Compliance (m/w/d)
Merck & Co., Inc.
Unterschleißheim, Germany
Qualified person (qp) certification eu 2019/6
Gmp compliance in sterile manufacturing
Team leadership of quality operations group
The role combines hands-on operational tasks with strategic leadership to ensure global product quality and patient safety
Job Summary
The role combines hands-on operational tasks with strategic leadership to ensure global product quality and patient safety.
Candidates will lead a team of seven, managing batch releases, GMP compliance, and continuous improvement initiatives within the biopharmaceutical sector.
The position requires high visibility on the shop floor, close collaboration with production teams, and representation at the site level in a global network.
Matching Summary
The role combines hands-on operational tasks with strategic leadership to ensure global product quality and patient safety.
Skills & Requirements
Must-have
Qualified Person (QP) certification EU 2019/6
GMP compliance in sterile manufacturing
Team leadership of Quality Operations group
Batch release authority responsibilities
Deviation management and complaint handling
Nice-to-have
Experience with aseptic validation processes
Strategic quality system development skills
Proactive problem-solving approach
Global network collaboration experience
Key Requirements
QP qualification per Article 97 Abs. 2 and 3 of Regulation (EU) 2019/6
Degree in Chemistry, Pharmacy, Biotechnology, or related field
Multi-year experience in pharmaceutical industry GMP requirements