eTools Quality Assurance Manager (QAM) (m/f/d) in Bremen

Working hours: Full-Time
Job Location: HQ, Bremen

GCP-Service International is a mid-size full-service Contract Research Organization (CRO) with headquarters in Bremen, Germany. Our satellite offices include locations in Potsdam, Siegburg, Netherlands, Poland, and Czech Republic. We conduct a wide range of clinical trials in both the pharmaceutical and medical device industries across the globe.

We are currently looking for a QA Manager to support our already existing QA Team and Head of Department in Bremen. Your key role will be to ensure quality, control of internal processes, compliance with relevant SOPs and regulatory requirements. Your key responsibilities will involve but not limited to Auditing and performing Quality checks of various clinical study databases, systems and application, Management of external audits/ regulatory inspections, Administering and maintaining internal electronic SOP system.

Qualifications needed:

  • Bachelor’s degree in Biological and/or information technology (IT) related field, Life science or any equivalent qualification and relevant work experience
  • Previous experience (at least 1 to 3 years) in similar role
  • Previous work experience in GMP or GCLP is an advantage
  • Excellent knowledge of various EDC and/or CTMS systems, validation process, related procedures, and regulatory requirements
  • General understanding of the clinical research process
  • Excellent competency in Microsoft office (Outlook, Excel, Word, PowerPoint, Teams)
  • Effective communication skills

We are a dynamic team looking for people who share our company values:

✓ Respect, acceptance and tolerance are the basis of a positive working environment
✓ We think that trust builds sustainability, stability, and creativity
✓ We reach a high grade of satisfaction by our flexibility
✓ Reliability must be the basis of a service provider
✓ Fair and honest interactions are the basis of our interpersonal relationships
✓ Continuous professional and personal development enables us to achieve and exceed expectations

In return, we offer a flexible working environment, well-structured support and guidance, a diverse and enthusiastic team, and competitive salary based on your experience.

If you see yourself the perfect fit for this role and our values, send your application to:

Petra Štěpánková
Head of Quality Assurance, Auditor
GCP-Service International Ltd. & Co. KG