Head of Quality

Vor 2 Tagen

Deutschland Meet Life Sciences Vollzeit

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.

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