Qa Manager Gene Therapy Quality /sachkundige Person Atmp
Roche
Mannheim, Germany
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Qp responsibility for gene therapies under §14 amg
Gmp compliance for viral vector-based therapies
Bulk and finp batch release authority
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Roche is seeking a QA Manager for Gene Therapy Quality in Mannheim, Germany. The role requires a qualified person responsible for ensuring compliance with national and European regulations in the production of advanced therapy medicinal products (ATMPs).
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Job Summary
This role serves as the Qualified Person (QP) responsible for the regulatory compliance and release of patient-specific cell and gene therapy products at Roche's new LSCDC center in Mannheim.
The position requires ensuring GMP-compliant manufacturing processes, managing complex deviations, and leading audits while fostering a supportive team environment focused on continuous improvement.
Roche offers a diverse range of top benefits designed to support employee life, finances, and health while contributing to a healthier future for patients globally.
Matching Summary
Match Score: 75
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Roche is seeking a QA Manager for Gene Therapy Quality in Mannheim, Germany. The role requires a qualified person responsible for ensuring compliance with national and European regulations in the production of advanced therapy medicinal products (ATMPs).
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Skills & Requirements
Must-have
QP responsibility for gene therapies under §14 AMG
GMP compliance for viral vector-based therapies
Bulk and FINP batch release authority
Complex deviation management and root cause analysis
National and international pharmaceutical law knowledge
Nice-to-have
Lean mindset culture and coaching skills
Experience in process and method transfer
Strong communication in German and English
Global interface experience with quality organizations
Ability to handle controversial topics openly
Key Requirements
Scientific degree required
Qualified Person (QP) certification per §15(3a) AMG
Multi-year QA experience in pharmaceutical manufacturing