Director, Clinical Quality Assurance

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Job description

Responsibilities:

· Serve as the primary contact in QA for the oversight of Clinical Studies in the US and Canada to ensure compliance with all GCP's from collection, labeling, distribution and site qualification to ensure compliance with all Regulatory requirements in the country the study is conducted

· Establish and maintain phase appropriate Quality Systems to support clinical studies. (including pharmacovigilance activities?). Implement (or assist with) GXP-compliant policies and procedures that are consistent, robust and integrated into the company's Quality Management System

· Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation

· Plan, oversee/perform and follow-up audits of CROs, external laboratories, clinical trial sites

· Establish/ensure/remediate as needed the current quality processes, systems and procedures associated with clinical studies

· Collaborate with cross-functional management, including the Head of Clinical, Medical Affairs, Regulatory Affairs, and Information Technology to drive clinical process improvements and alignments

Requirements: CELL THERAPY EXPERIENCE STRONGLY PREFERRED

· BS or MS preferred with 5+ years of experience in the pharmaceutical, Biologics or health industry with demonstrated knowledge or experience in GCP Compliance

· Thorough understanding of clinical drug development, GCP, and familiarity with regulatory (FDA, Health Canada, and other global regulations) requirements for the conduct of clinical trials, including investigator-initiated studies

· Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.

· The ability to represent QA cross-functionally and globally; to apply understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas

· Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems

· GCP Quality Assurance registration/certification preferred