Quality Assurance Manager

Qualified Person (QP) – Germany | Pharmaceutical Manufacturing

Location : Germany (Multiple Locations / Hybrid)

Employment Type : Permanent / Contract

Industry : Pharmaceutical Manufacturing

Are you a certified Qualified Person (QP) looking to play a key role in ensuring the quality, safety, and compliance of pharmaceutical products?

We are partnering with leading pharmaceutical manufacturers across Germany who are seeking experienced QPs to support batch certification, regulatory compliance, and quality oversight within GMP-regulated environments.

Key Responsibili ties

• Perform QP batch certification and release activities in accordance with EU GMP requirements.
• Ensure products are manufactured, tested, and released in compliance with regulatory standards.
• Provide expert guidance on GMP compliance, quality systems, deviations, CAPAs, and change controls.
• Support regulatory inspections and interactions with competent authorities.
• Review manufacturing and quality documentation to ensure inspection readiness.
• Collaborate with Quality Assurance, Manufacturing, Regulatory Affairs, and Supply Chain teams.
• Drive continuous improvement initiatives across quality systems and operational processes.

Requirements

• Qualified Person status in accordance with EU Directive 2001/83/EC.
• Proven experience within pharmaceutical manufacturing, biotechnology, or advanced therapies.
• Strong knowledge of EU GMP regulations and quality systems
• Experience with batch release, deviation management, CAPA, and change control processes.
• Previous exposure to regulatory inspections and authority interactions.
• Excellent stakeholder management and communication skills.
• Fluent German and English preferred.

Desirable Experience

• Sterile manufacturing, biologics, ATMPs, vaccines, or highly regulated pharmaceutical products.
• Experience supporting site readiness for inspections.
• Multi-site or international manufacturing experience.

What's on offer?

• Opportunities with leading pharmaceutical and biotechnology organisations.
• Competitive compensation packages.
• Flexible working arrangements depending on site requirements.
• Career progression within high-growth manufacturing environments.
• The opportunity to make a direct impact on patient safety and product quality.