Quality Assurance Leader Germany PDx - Pharmaceutical Entrepreneur and Marketing Authorisation Holder (f/m/d)
Core
Senior quality authority establishing governance frameworks for German Pharmaceutical Entrepreneur and Marketing Authorisation Holder (MAH) activities to ensure regulatory compliance and patient safety.
Role type
Senior IC Quality Assurance Leader (Pharmaceutical Entrepreneur/MAH)
Builds
Quality governance systems, compliance frameworks, and risk management processes for German PDx business
Domain
Pharmaceutical industry, Regulatory Compliance, Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality governance, GMP/GDP compliance, MAH/Pharmaceutical Entrepreneur operations, Regulatory inspection management, Quality risk management, Supplier oversight, Leadership in regulated environments
Preferred skills
Qualified Person (QP) experience, Responsible Person (RP) experience, Advanced degree in Life Sciences
Technologies
EU GMP, EU GDP, German Arzneimittelgesetz (AMG), Risk management methodologies
Responsibilities
Define and implement quality strategy for German PDx business, Ensure compliance with MAH and Pharmaceutical Entrepreneur obligations, Lead inspection readiness and represent organization during regulatory audits, Oversee product lifecycle quality issues including recalls and market actions, Manage third-party quality oversight of contract manufacturers, Advise senior management on emerging quality and compliance risks
Seniority
Senior, hands-on IC with strategic influence