Senior Quality Assurance Manager / Qualified Person (m/w/d)
Institutehumanbiology
Mannheim, Baden-Württemberg, Germany
Gmp-compliant batch release
Process harmonization and improvement
Quality oversight and audit participation
As Senior Quality Assurance Manager / Qualified Person, you will lead quality assurance processes ensuring GMP-compliant and timely release of pharmaceutical batches primarily on-site in Mannheim
Job Summary
As Senior Quality Assurance Manager / Qualified Person, you will lead quality assurance processes ensuring GMP-compliant and timely release of pharmaceutical batches primarily on-site in Mannheim.
The role includes responsibility as Qualified Person under §14 AMG, overseeing batch confirmation, regulatory compliance, and coordination of quality oversight and audits.
Roche offers attractive benefits including a long-term account for financing sabbaticals or retirement transition, a supplementary pension plan, and a strong focus on work-life balance at the Mannheim location.
Matching Summary
As Senior Quality Assurance Manager / Qualified Person, you will lead quality assurance processes ensuring GMP-compliant and timely release of pharmaceutical batches primarily on-site in Mannheim.
Skills & Requirements
Must-have
GMP-compliant batch release
Process harmonization and improvement
Quality oversight and audit participation
Root cause analysis of quality events
Coordination with international interfaces
Pharmaceutical manufacturing quality assurance
Nice-to-have
Lean-Mindset culture promotion
Strong communication skills in German and English
Team player with coaching abilities
Entrepreneurial mindset
Continuous process improvement
Key Requirements
Pharmacy degree with pharmacist license
7-10 years pharmaceutical industry experience
Qualified Person certification under §14 AMG
Extensive GMP knowledge and pharmaceutical manufacturing experience
Knowledge of national and international pharmaceutical law (AMG, AMWHV, EU, FDA, Japan)