Clinical QA Leadership Position
Vor 5 Tagen
We are seeking an experienced Clinical QA professional to join our team as a Senior Manager of Clinical QA. This role will provide GCP oversight of Clinical Development teams, execute and manage Incyte QA GCP audits, and provide GCP guidance and advice across assigned Clinical Development programs.
Key Responsibilities- Provide QA GCP advice and support to Incyte Clinical Development/Operations functions and other relevant functions as assigned.
- Plan, schedule, and conduct audits of Clinical Investigator Sites, Vendors, Partners/Affiliates, and Clinical submission documents.
- Conduct GCP training for Incyte staff.
- Assist with the maintenance of the Clinical Quality Management System, including QA support for change control, deviations, review/revision of SOPs with ensuring continuous process improvement.
- Coordinate responses and corrective/preventative actions from deviations, audit, and regulatory findings.
To be successful in this role, you will need:
- Bachelor's degree in a science or healthcare-related discipline, or similarly conferred degree from a University.
- 2-10 years' experience in a pharmaceutical or bio-pharmaceutical company in a GCP Quality Assurance role or Clinical compliance role.
- Minimum of 1 year experience performing GCP audits of investigator sites and/or CROs or comparable GxP audits experience.
- English fluency written and spoken (the company language).
- Ability to travel up to 30%.
Incyte is a global biopharmaceutical company dedicated to advancing innovative medicines to improve patients' lives. We are committed to creating a workplace culture that values diversity, inclusion, and collaboration.
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