Associate Director Quality Assurance
Associate Director, GCP Quality Compliance - Remote
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:
10 years of experience in the pharmaceutical industry; 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.
Apply Now
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:
10 years of experience in the pharmaceutical industry; 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.
Apply Now