Quality Assurance Manager & GCP Auditor

Preferred Location: Germany or the Czech Republic

The Quality Assurance Manager plays a key role in safeguarding the quality, integrity, and compliance of our clinical research activities. This position combines independent quality oversight with auditing responsibilities across internal processes, sites, systems, projects, and service providers, while supporting adherence to GCP-Service SOPs and alignment with national and international regulatory requirements.

If you enjoy working in a structured environment, improving systems, and contributing to high-quality clinical research, this is an excellent opportunity to make a meaningful impact.

Responsibilities

In this role, you will be responsible for the following:

Auditing

• Plan, prepare, conduct, and document GCP audits, with a primary focus on investigator site audits.
• Conduct other types of internal and external audits, including system, process, project compliance, service provider, sponsor, and vendor audits.
• Prepare audit reports, communicate audit observations, and follow up on resulting actions and CAPAs.

Vendor Qualification and Oversight

• Support the selection, qualification, and ongoing oversight of vendors and service providers from a quality and compliance perspective.

Quality Systems and Compliance

• Manage CAPAs, track their progress and effectiveness, and support the continuous improvement of the QMS.
• Support investigations of compliance issues reported to QA, including root-cause analysis and follow-up actions.
• Escalate critical compliance issues and support the identification and mitigation of Critical to Quality factors and quality risks.

Documentation and SOP Management

• Provide QA guidance on SOPs and controlled documents.
• Support the development, review, maintenance, and continuous improvement of company SOPs, forms, and related controlled documentation, including management of deviations and follow-up actions.

Collaboration and Professional Contribution

• Communicate proactively with team leads, process owners, and CAPA owners.
• Contribute to meetings, projects, and training activities and proactively propose practical solutions.
• Support general QA activities and administration in accordance with company SOPs and the QMS.
• Stay informed about company services, stakeholder needs, applicable regulations, and industry standards.
• Travel regularly as required for investigator site and other audits, including overnight stays.

Requirements

We are looking for a candidate who brings the following:

Education and Clinical Research Experience

• Degree in Life Sciences or an equivalent biological or medical qualification, or relevant clinical research experience.
• At least 3-5 years of experience in clinical research, life sciences, or a related QA environment.

Auditing and Regulatory Expertise

• At least 3 years of experience as a Quality Assurance Manager and GCP auditor, with the ability to act independently and objectively.
• Strong understanding of Good Clinical Practice (GCP) and applicable national and international regulatory requirements.

Quality Systems and Process Knowledge

• Solid knowledge of the clinical research process and practical experience with quality systems, CAPA management, or compliance activities.
• Monitoring experience, ideally in an international setting, is an advantage.

Communication and Working Style

• Strong communication skills and the ability to work independently, collaboratively, and with an open-minded, structured, solution-oriented approach.
• Proficiency in Microsoft Office.