About this job

We are looking for an experienced leader as Head of Quality*, who will be responsible for our Quality Unit (Quality Assurance & Quality Control) and will have clear decision-making authority to ensure product quality and compliance with GMP requirements – nationally and internationally (EU & USA/FDA).

Your work focus

• Management of the Quality Unit in accordance with 21 CFR 210/211
• Final decision-making body for batch disposition and quality release in accordance with FDA quality unit requirements.
• Professional and disciplinary management of QA and QC
• Responsibility for GMP compliance, validation strategy, PPQ & lifecycle management
• Primary contact for FDA and EU authorities
• Close cooperation with the EU Qualified Person (QP) for statutory EU batch certification

Your building blocks for shared success

• Studies in natural sciences, pharmacy, or a comparable field
• Several years of experience in a management position in a GMP environment (ATMP is an advantage)
• Verifiable responsibility for QA, QC or Quality Unit
• Excellent knowledge of:
• EU-GMP (including ATMP environment)
• FDA requirements (21 CFR 210/211)
• Quality Risk Management (ICH Q9)
• Experience with regulatory inspections (FDA, EMA, national authorities)
• Integrity, a sense of responsibility, and a cooperative, clear leadership style
• Ability to represent quality requirements independently, objectively and in a manner appropriate to the target audience.
• Reliable prioritization and decision-making ability even in a dynamic environment
• Strong communication skills at management and government levels
• Very good German and English skills

We offer you this

• Permanent full-time position with attractive remuneration
• Flexible individual mobility budget and free parking
• Free drinks and fresh fruit for the workday
• Extensive corporate benefits
• Occupational pension scheme
• Diverse further education and development opportunities
• A motivated, supportive and collegial team
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