What are the responsibilities and job description for the Associate Director, GCP Quality Assurance position at Skills Alliance?
Associate Director, GCP Quality Assurance
Job Type: Permanent
Location: New Jersey, NJ - 2 days per week on site
Salary: $160K - $200K Bonus Benefits
Opportunity to work with a mid-sized Biopharma who focus on oncology and neurology, including groundbreaking treatments for dementia and neurodegenerative diseases. They strive to increase the benefits of healthcare through their therapies and have a self-promoting culture of compliance and integrity.
This position oversees GCP compliance activities; CROs, and Investigator Sites by leading audits and inspection readiness to ensure high-quality clinical trial execution from first-in-human through commercialization.
Responsibilities:
- You will offer GCP quality assurance support for clinical development to ensure patient safety, maintain data accuracy, and promote operational efficiency.
- Perform audits independently, including audits of clinical investigator sites, vendors, GCP-related documents internal processes, and assist with system audits.
- Create and manage audit plans and reports.
- Drive continuous quality improvement by sharing audit findings, CAPAs, and provide GCP guidance and advice to clinical teams.
- Lead inspection preparation activities for health authorities and oversee inspections to ensure compliance.
- Review and provide feedback on clinical documents such as protocols, study reports, Investigator Brochures, and Informed Consent Forms.
- Deliver GCP training sessions to educate business teams on compliance and best practices.
Requirements:
- 9 years’ experience in Biotech GCP Quality
- 7 years' Clinical Quality Assurance Auditing
- Recent exposure of inspection management / readiness
- Recent exposure of being a representative of the CQA Department
Please reach out to David.fearnley@skillsalliance.com or call 1 917 692-1913 for further details.
Salary : $160,000 - $200,000
