Senior Quality Assurance Manager

About the role

We are seeking an experienced and motivated Senior Quality Assurance (QA) Manager – Clinical Trials to further develop our QA function within the clinical research environment. This role combines hands-on quality expertise with close collaboration with cross-functional and international stakeholders.

Responsibilities

• Plan, conduct, report and track internal and external audits (e.g. process audits, vendor qualification audits, system and study specific audits and inspections)
• Ensure compliance with GCP, ICH guidelines, FDA regulations, applicable regulatory requirements, and company standards
• Own and manage Deviation and CAPA processes, including root cause analysis, tracking, and effectiveness checks
• Drive risk management activities, including risk assessments and mitigation strategies
• Lead and support change management processes related to quality systems and clinical operations
• Responsible for the creation, review, approval, and lifecycle management of QA SOPs
• Preparation of role-based training materials and conduct of training courses in the GCP/FDA regulated setting
• Prepare quality metrics, management reports, and audit summaries for upper management
• Act as a key QA contact for regulatory inspections and sponsor audits
• Collaborate closely with Clinical Operations, Project Management, Regulatory Affairs, Data Management, Medical Writing and external partners
• Support continuous improvement initiatives within the Quality Management System (QMS)
• Review and approve validation documentation (e.g. validation plans, risk assessments, test scripts, validation reports) for computerized systems, including eQMS and other GxP-relevant systems

Qualifications

• University degree in Life Sciences, Pharmacy, Medicine, or a related field
• Several years of professional experience in Quality Assurance within clinical trials
• Senior QA professional
• Strong knowledge of GCP, ICH and international regulatory requirements (e.g. FDA regulations)
• Demonstrated experience in:
  • Audit planning, performance, and reporting
  • Deviation and CAPA management
  • Risk management
  • Change management
  • SOP and training management
• Willingness to travel nationally and internationally, particularly within/to Germany, within Europe and the USA
• Strong organizational, analytical, and problem-solving skills
• Confident communication style and ability to work with stakeholders at all levels

What We Offer

• A responsible senior role in an international clinical research environment
• High level of autonomy and the opportunity to actively shape QA processes
• Collaboration with global teams and exposure to international projects
• A thorough and practice-oriented onboarding
• Performance-based compensation and flexible working hours
• A company culture strongly characterized by trust and collegiality
• An exciting workplace with opportunities for professional and personal development, for example development into a team lead function