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Associate Director, Clinical Quality Assurance / GCP QA
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- In 2021, we expanded our portfolio with the acquisition of Constellation Pharmaceuticals, and we are continuing to emerge as a leader and future powerhouse in hematology-oncology.
- Associate Director, Clinical Quality Assurance / GCP QA at Constellation will be responsible for providing leadership and direction for ongoing clinical projects, cross-functional teams, and at management review meetings on Good Clinical Practice (GCP) related activities/issues, and act as a GCP expert.
- Develop and implement Good Clinical Practice (GCP) / Good Pharmacovigilance Practice (GVP) / Good Laboratory Practice (GLP) compliance risk-based audit strategies and master audit plans; includes the management, planning, conduct, approval, and close-out of audits (e.g. for a specific clinical development drug program(s) or subtype of audit), if applicable, working closely with Contract Research Organization personnel or consultants to prepare, conduct and report outsourced audits;
- Associate Director, Clinical Quality Assurance / GCP QA will report directly to MorphoSys’ Group Leader GCP/GVP/GLP based in Germany and indirectly to MorphoSys’ Head of Global Quality Operations.
- Bachelor’s degree in Biotechnology, Regulatory Science, Pharmaceutics or Pharmaceutical Science or Industrial Pharmacy (or its foreign equivalent); plus 8+ years of quality assurance experience within the pharmaceutical drug development industry as a Quality Assurance Manager, Lead, Specialist or Associate;OR
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