Quality Manager, Quality Assurance

About the role

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications, partnering with small to midsize biotech companies on early-phase trials. The Quality Manager, Quality Assurance fosters a culture of quality within the company and acts as an ambassador for the QA department. The role leads the design, implementation and management of internal and vendor audits and the related quality risk management activities.

Key responsibilities

• Develop and maintain the internal Quality Risk Assessment methodology and a comprehensive Audit Universe.
• Lead QA activities related to procurement and vendor oversight, and manage mechanisms ensuring ongoing compliance with laws and regulations such as EU GVP, US FDA CFRs, JMPA and ICH-E6.
• Partner with Vendor Management and operations teams on a risk-based, compliant audit strategy.
• Coordinate internal system and vendor audits according to the company audit plan, including pre- and post-audit activities, and conduct or coordinate audit documentation peer review and quality control within the area of GxP expertise.
• Support client-contracted Quality as a Service activities, such as planning, coordinating or conducting audits and providing GxP QA consultancy.
• Monitor compliance within the organization and review its impact on audit strategy, plans and execution.

Required profile

• Bachelor's or Master's degree in biomedical sciences, natural sciences, health sciences or another relevant scientific discipline, or an equivalent combination of advanced education and industry experience.
• Experience with GVP and GCP regulatory requirements, or a willingness to broaden expertise in them.
• At least 3 years of direct auditing experience in GCP (e.g. investigational sites, TMFs, vendors) and/or GVP (e.g. safety case processing and reporting).
• At least 2 years of experience in audit program management, including developing and maintaining risk-based audit plans.

Required skills

• Organization skills and attention to detail.
• Excellent communication and facilitation skills within a global organization.
• Proactive approach and fluency in English.