Director of GCP Compliance (R&D QA)
An established and innovative pharmaceutical is looking to bring on a Director of Clinical QA to join its growing team. This role will assume ownership over the QMS and be partnering directly with different stakeholders to drive QA throughout the company.
- The strategy, implementation & leadership of the GCP Compliance function
- Execution and administration of the GCP Quality System compliant with ICH, US and EU regulations
- All aspects of GCP Compliance, from strategic planning to hands-on implementation
- Identify risks and suggest mitigation plans related to assigned projects
- Lead preparations for and management of any Regulatory Agency inspections
- Provide leadership & mentorship to the organization
- Collaborate with Supplier Quality to determine appropriate vendor use
- Review and approve responses and corrective actions related to audit activities and reports.
- Plan & oversee day-to-day activities of the GCP Compliance including management of consultants/auditors as needed, to ensure project & business needs are met
The ideal candidate will have the following skill set:
- 10 years of experience in the pharmaceutical, device or diagnostic industry with at least 7 of those years in GCP Compliance
- BA/BS or Master's Degree (or higher) in a scientific discipline or equivalent combination of education and experience is required.
- Strong communication and collaboration skills