We're currently partnered with a a privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies. They're currently going through a growth period within their Quality department and one of their open positions, is Director/SD, Clinical QA.
This critical position will collaborate with internal clinical and nonclinical functional groups and external parties including consultants, contract auditors, CRO/Service Provider personnel, and Investigator Sites to promote a high level of quality and consistency across all development programs. This includes a risk-based approach to Quality Management for all programs. Additionally, this position will independently manage domestic and international risk-based audits of Investigator Sites, clinical vendors, study databases, partners or collaborators (as applicable). The Director of CQA will also support internal quality systems with the creation, review, and adherence to company policies, and procedures and adhering to GxP requirements.
- Minimum of a Bachelor of Science (B.S.) degree in a scientific, life science, or medical/technical discipline.
- Minimum of 10 years’ experience within the pharmaceutical industry with at least 8 years of experience in a GCP or CQA quality role, with increasing levels of responsibility.
- Minimum of 5 years’ experience in leading or independently performing CQA audits (Vendor qualification/routine/for-cause, Investigator Site, Gap Assessment, TMF, CSR, etc.), and audit CAPA management.
