Quality Assurance Manager & GCP Auditor

GCP-Service International Ltd. & Co.KG; Deutschland; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

GCP-Service International Ltd. & Co.KG is seeking a Quality Assurance Manager with strong GCP auditing expertise to safeguard quality and regulatory compliance across clinical research activities.

The role combines independent QA oversight with audits of processes, sites, and vendors, supporting CAPA processes and continuous improvement while staying aligned with SOPs and international standards. Travel may be required.

Qualifications

• Minimum 3 years as a Quality Assurance Manager and GCP auditor.
• Strong knowledge of GCP and applicable regulatory requirements.
• Experience with quality systems, CAPA management, and compliance activities.

Responsabilités

• Provide QA oversight and audits across internal processes, sites, systems, projects and service providers.
• Manage SOPs, deviations, and CAPA follow-up actions.
• Lead regulatory alignment and GCP compliance throughout the organization.
• Monitor QMS performance and support investigations into compliance issues.

Connaissances

Quality Assurance

GCP auditing

Regulatory knowledge

CAPA management

Quality systems

Communication

Formation

Degree in Life Sciences or equivalent

3-5 years clinical research experience

Outils

Microsoft Office

Description du poste

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:

Documentation and SOP Management

• Provide QA guidance on SOPs and controlled documents, and manage the development, review, improvement, deviations, and follow-up actions for company SOPs, forms, and related documentation.

Audits and Vendor Oversight

• Conduct internal and external audits, including site, system, process, project compliance, service provider, sponsor, and vendor audits.
• Support vendor selection, qualification, and ongoing oversight.

Quality Systems and Compliance

• Manage CAPAs, track progress, and support continuous improvement of the QMS.
• Support investigations into compliance issues reported to QA, including root-cause analysis.
• Escalate critical compliance issues and support Critical to Quality and risk identification and mitigation.

Collaboration and Professional Contribution

• Communicate proactively with team leads and process and CAPA owners.
• Contribute to meetings, projects, and training, and propose solutions.
• Support QA administration and follow company SOPs.
• Stay informed on services and stakeholder needs.
• Keep up to date with industry standards.
• Travel as needed, 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.