Head of Quality

Overview

We are seeking an experienced Head of Quality Assurance to lead all GxP‑related quality activities across clinical development programs, with a primary focus on GMP , GCP , and Clinical Safety . This role combines strategic leadership with hands‑on oversight, ensuring product quality, patient safety, and regulatory compliance across both internal operations and external partners, including CMOs, CDMOs, and CROs.

Key Responsibilities

• Lead the QA function and take full ownership of the Quality Management System (QMS) across all GxP areas.
• Assess the need for and guide the transition toward an electronic QMS .
• Develop and implement risk‑based quality management approaches in a GxP environment.
• Define and maintain a Quality Strategy aligned with regulatory expectations (ICH Q10, EU GMP, 21 CFR 210 / 211, 600, 820).
• Plan and oversee internal and external audits across all GxP domains.
• Ensure inspection readiness for all GMP- and GCP-governed functions.
• Provide quality leadership as a member of the Development Leadership Team / Product Lifecycle Team , influencing CMC, regulatory, and clinical operations.
• Establish a phase‑appropriate QMS suitable for a small biotech environment with outsourced manufacturing.
• Cultivate a strong quality culture focused on transparency, accountability, and continuous improvement.

Requirements

• Advanced degree in life sciences, pharmacy, or medicine.
• 10+ years of experience within the pharmaceutical / biotech sector, including at least 5 years in Quality Assurance .
• Background in clinical development (required).
• Proven track record in preparing for and managing regulatory inspections .
• Comprehensive knowledge of global GxP regulations , with strong expertise in GCP .
• Strong leadership skills and ability to operate effectively in a matrixed environment .
• Excellent analytical, problem‑solving, and communication abilities.
• Fluent in English; good command of German is an advantage.
• Willingness to travel as needed.