Head of Quality / QP

We are partnered with a global healthcare solutions company focused on personalized medicine and pharmaceutical compounding support, providing high-quality ingredients, technologies, and services that enable customized patient care. The organization combines innovation, regulatory expertise, and international collaboration to support evolving healthcare needs worldwide.

Responsibilities

• Define and execute site-wide quality and compliance strategy within a GMP/GDP-regulated EU environment.
• Establish and maintain GMP-, GDP-, and ISO-compliant management systems (ISO 9001, 14001, 50001) and ensure continuous audit and inspection readiness.
• Act as Qualified Person (QP) in accordance with §15 AMG and EU-GMP Annex 16, performing batch certification and release decisions.
• Review batch documentation and evaluate deviations, OOS/OOT results, complaints, and changes to determine release or escalation.
• Serve as primary interface with regulatory authorities, auditors, and certification bodies, supporting inspections and licensing activities.
• Oversee CAPA, risk management, and quality governance, ensuring effective collaboration across QA, QC, and external partners.
• Support validation, data integrity, and oversight of outsourced quality activities.
• Lead and develop the quality organization while promoting a strong quality culture.

Requirements

• Degree in pharmacy, chemistry, or a comparable natural science discipline; eligibility as Qualified Person according to §15 AMG.
• Several years of leadership experience in a GMP-regulated pharmaceutical environment, including batch release responsibilities.
• Strong knowledge of EU-GMP (especially Annex 16), GDP, ISO management systems, and regulatory requirements.
• Experience interacting with regulatory authorities, audits, and inspections.
• Strategic mindset, strong decision-making skills, and high sense of responsibility.
• Excellent communication skills with fluency in German and English.