Qualified Person Als Quality Operations Group Lead Compliance (m/w/d)
leHACK
Unterschleißheim, Germany
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Qualified person (qp) certification eu 2019/6
Gmp compliance in sterile manufacturing
Team leadership of quality operations group
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leHACK is seeking a Qualified Person as Quality Operations Group Lead Compliance in Unterschleißheim, Germany. The role blends hands-on responsibilities with leadership in ensuring compliance with GMP standards in the biopharmaceutical production process.
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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 GMP compliance across global production networks while maintaining high visibility on the shop floor.
Candidates will lead strategic quality improvements, manage batch releases, and support regulatory inspections within a biopharmaceutical environment.
Matching Summary
Match Score: 75
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leHACK is seeking a Qualified Person as Quality Operations Group Lead Compliance in Unterschleißheim, Germany. The role blends hands-on responsibilities with leadership in ensuring compliance with GMP standards in the biopharmaceutical production process.
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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 development of quality systems
Proactive problem-solving approach
Hands-on operational presence on shop floor
Key Requirements
QP qualification per Article 97 Abs. 2 and 3 EU Regulation 2019/6