Role Overview:

In this hybrid role, you ensure GCP compliance and maintain quality standards in clinical research. Work with internal teams and external partners to uphold regulatory requirements and safety.

Key Responsibilities:

• Plan and conduct risk-based GCP audits (sites, vendors, internal processes).
• Manage CAPAs and ensure compliance with GCP guidelines.
• Develop and update SOPs, policies, and checklists.
• Implement risk mitigation strategies.
• Conduct GCP training programs.
• Analyze and report quality metrics to senior management.

Qualifications:

• 4-5 years of GCP QA experience in pharma or health authority.
• Degree in Life Sciences, Pharmacy, or related field.
• Strong knowledge of GCP, ICH-GCP, and global regulations (EMA, FDA, MHRA).
• Understanding of clinical trial methodologies and quality systems.
• Fluent in German & English (C1+).

Benefits:

• Supportive, collaborative team environment.
• Career development & learning opportunities.
• International, family-owned company with short decision-making processes.
• Flexible work hours, remote options.
• Health, sports, canteen, and mobility benefits.
• Structured onboarding & mentoring.