Director, Clinical Quality Assurance (GCP)
$204,000–$246,750 year
On-siteJersey City, New Jersey, United States
Job Summary
Lead and manage the Clinical Quality Assurance audit program, ensuring compliance with GCP, applicable regulations, and company SOPs. Develop and execute risk-based audit plans to conduct internal, site, and vendor audits, while providing expert guidance to cross-functional teams on protocol adherence and regulatory requirements. Own the inspection-readiness strategy across the clinical development portfolio, representing the company in regulatory inspections and leading mock inspections. Mentor CQA staff and contract auditors, contribute to departmental strategy and budget planning, and develop GCP training programs for internal and external partners. Review essential study documents including protocols and clinical study reports, and collaborate with the Clinical Operations team to address quality-related deviations. This role requires a minimum of 3 days per week onsite in Jersey City or Millbrae, with up to 50% travel.
Required Qualifications
- 12+ years of progressive experience in clinical quality assurance or a related field in the pharmaceutical or biotechnology industry
- Bachelor's degree
- 10+ years of equivalent experience with an advanced/post-graduate degree
- Extensive knowledge of GCP guidelines, ICH E6(R2), and other relevant regulatory requirements
- Strong leadership, analytical, and problem-solving skills
- Meticulous attention to detail and accuracy
- Exceptional communication and interpersonal skills
- Proven ability to lead and collaborate in a cross-functional team environment
- Demonstrated experience in conducting clinical trial audits and inspections
- Ability to travel up to 50% (domestic and international)
- Minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices
Desired Qualifications
- Additional certifications (e.g., RAC, CQA)
- Previous experience in pharmacovigilance auditing
- Expertise in Veeva systems
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