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
Batch release authority and decision making
This role combines the technical responsibility of a Qualified Person with genuine leadership duties for a team of seven employees
Job Summary
This role combines the technical responsibility of a Qualified Person with genuine leadership duties for a team of seven employees.
The position requires ensuring all materials and products meet strict quality standards and regulatory requirements across a global production network.
Candidates must possess deep knowledge of GMP regulations, particularly in sterile pharmaceutical manufacturing, to oversee batch releases and site inspections.
Matching Summary
This role combines the technical responsibility of a Qualified Person with genuine leadership duties for a team of seven employees.
Skills & Requirements
Must-have
Qualified Person (QP) certification EU 2019/6
GMP compliance in sterile manufacturing
Batch release authority and decision making
Team leadership of Quality Operations group
Deviation management and complaint handling
Nice-to-have
Experience in aseptic validation processes
Strategic development of quality systems
Hands-on operational presence on shop floor
Proactive problem-solving approach
Global network collaboration experience
Key Requirements
Qualified Person qualification per Article 97 EU 2019/6