Head of Clinical Quality Assurance (GCP Compliance)
- Greater Boston Area
- Extremely Competitive Compensation Package
One of the highest performing pharmaceutical companies in the world is looking to bring on a Head of Clinical QA-GCP to join its growing team. This role will be partnering directly with the R&D team to lead and drive a culture of quality in all aspects of research across key therapeutic areas.
If you are seeking to join an industry leading company and develop clinical QA strategy going into 2020, than don't hesitate to apply!
- 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.
- Good communication and collaboration skills
