Site Quality Head (all genders)

The Site Quality Head is responsible for all Quality Assurance (QA), Quality Control (QC), and compliance activities across clinical and commercial manufacturing operations at the assigned site. This leader ensures that all processes adhere to regulatory requirements (e.g. AMG, FDA, EMA, PMDA, GCTP), internal standards, and client quality agreements. As a core member of the Site Leadership Team and Global Quality Leadership Team, this role fosters a culture of quality, risk management, and continuous improvement.

Your Responsibilities:

• Serve as the site’s senior-most quality authority, ensuring that quality principles and standards are fully embedded into all departments and daily operations.
• Act as the final decision-maker for product quality-related escalations and batch release, safeguarding patient safety and regulatory compliance.
• Ensure the site is maintained in a constant state of regulatory inspection readiness, in alignment with global GMP and GCTP requirements.
• Lead preparation, hosting, and response efforts for Health Authority inspections (e.g., FDA, EMA, PMDA) and client audits.
• Communication with authorities for example in case of introduction of new products into the facility, follow to health authorities
• Ensures screening for new regulations and performance of assessments of readiness of the facility for new regulations
• Collaborate with global, site leadership and cross-functionally to implement regulatory strategies and remediation plans where gaps are identified.
• Ensure all site licenses, certifications, and registrations are current and compliant with evolving regulatory landscapes.
• Oversee the implementation and maintenance of a robust Quality Management Systems 
• Maintain group of Qualified Persons to release products according to EU regulations
• Collaborate with global and site leadership to support the deployment and sustainability of electronic systems, for example QMS,Laboratory Information Management Systems (LIMS) and Manufacturing Execution System (MES) in line with global standards.
• Present the quality strategy to clients and manage client interactions for all quality related issues
• Prepare, negotiate, and approve Quality Agreements with clients and critical material vendors based on approved global templates.
• Provide strategic oversight for Quality Control operations, ensuring timely and accurate in-process and release testing aligned with regulatory and client expectations (aligned with specific site responsibilities).
• Ensure data integrity and regulatory compliance across all site activities, including manufacturing, microbiological and bio-analytical testing.

Your Profile:

• Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• 10+ years of senior leadership experience in QA/QC roles within regulated biopharma or ATMP manufacturing.
• Deep knowledge of GMP, aseptic manufacturing, and analytical QC practices.
• Familiarity with GCTP requirements and Japanese regulatory obligations is a plus.
• Strong communication and executive presentation skills.
• Experience with global quality systems, compliance audits, and regulatory
• Strong cross-functional leadership in both line and matrix organizations.
• Able to drive change, manage ambiguity, and build resilient quality systems.
• Demonstrated success in coaching and developing high-performing teams.
• Models the highest ethical standards and decision-making.
• Proficient in root cause analysis, risk management, and regulatory strategy.
• Proficient in German and English (both written and spoken)
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Minaris Regenerative Medicine GmbH ist ein globaler Partner für Auftragsforschung und Lohnherstellung. Wir produzieren hochmoderne Zell- und Gentherapien nach den Vorgaben der Guten Herstellungspraxis (GMP) für die Anwendung im Menschen. Bei uns tragen Sie aktiv zum medizinischen Fortschritt bei und geben schwer kranken Patienten Hoffnung.