Associate Director, GCP Quality Compliance
Summary
An industry leader in regenerative health and pain management (non-opioid) is seeking a driven Associate Director, GCP Quality Compliance to join their team. As a Clinical Quality leader working in concert with executive leadership - this person will be developing and executing a comprehensive CQA audit infrastructure as well as continuing to build and maintain key vendors and supplier relationships. This individual will join a passionate team that is dedicated to advancing better health outcomes for patients in need. They pursue this mission through an inclusive culture of innovation, collaboration and growth mindsets.
Responsibilities:
- Develop and maintain the annual audit plan and clinical vendor/supplier list in collaboration with relevant departments.
- Plan, schedule, and conduct external audits of clinical investigator sites, vendors, CROs, and internal processes.
- Follow up on audit activities, including reviewing and approving responses, and developing corrective action plans for deviations.
- Provide quality assurance oversight to ensure compliance with regulatory requirements and lead inspections and audits by regulatory agencies.
- Act as the quality liaison for clinical programs, drive process improvement initiatives, and ensure completion of regulatory commitments.
- Oversee global regulatory inspections and ensure completion of related commitments.
- Collaborate with clinical development functions to ensure compliance and act as a quality liaison.
- Identify and lead internal process improvement initiatives, including inspection readiness activities.
Education and Experience:
- Minimum of 10 years of experience in the pharmaceutical industry, with at least 8 years in GCP quality assurance.
- Bachelor's degree required, preferably in a scientific discipline.
Knowledge, Skills, and Abilities:
- Ability to manage multiple projects and responsibilities independently with minimal supervision.
- Strong knowledge of ICH GCP guidelines, GVP regulations, and relevant regulatory requirements.
Join in Making a Difference!
If you are passionate about improving patient outcomes and thrive in a dynamic, innovative environment, this is the next step for you. Apply now to join this dedicated team and lead the way in clinical quality compliance.
