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Clinical QA Manager

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19 FEB '24: This visionary biopharmaceutical organisation that's revolutionising healthcare through cutting-edge biotechnology and groundbreaking pharmaceuticals is currently seeking a driven Quality professional with solid GCP/Clinical research experience to join the team. They're passionately dedicated to improving patient lives globally, using innovative research and advanced technologies to create life-changing treatments.

Details

Biotechnical

Quality/RA

Leiden - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

In this role, you will lead and supervise the Clinical Quality team within a global biopharmaceutical organisation focused on rare, debilitating and life-threatening diseases. Your GCP and GVP experience ensure you to be in a constant state of inspection readiness. Additionally, you will ensure the compliance of the clinical studies according to the organisation its SOPs and other global regulations. Furthermore, you will focus on leading the team and ensure training & further qualifications; reviewing and approving all clinical and PV QMS documents; collaborating with other departments to ensure GxP compliance; resolving problems and investigating deviations/complaints/non-conformities/CAPAs/etc.; perform internal/external audits and eTMF audits; participate in projects as CQA SME.

QTC logo icon what's needed

What you bring

With an M.Sc. degree in Life Science discipline and extensive experience (8+ years) in the biopharmaceutical industry, the right candidate brings along:

 

  • 6+ years in Quality Assurance with a sound understanding of GCP and GVP guidelines;
  • Proven line manager with the ability to positively develop a team;
  • Ability to occasionally travel for the audit program.

QTC logo icon What we offer

What's in it for you

In this role, you will bring along the missing expertise and provide impact into the entire span of the organisation from a Quality perspective. Furthermore, the package includes: 

 

  • Competitive base salary, tailored to experience;
  • Bonus opportunity, performance-based;
  • 30 holidays;
  • Excellent pension plan;
  • Tailor-made Learning & Development program;
  • Travel allowance.

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