Associate Director Quality Assurance

EPM Scientific; Morristown (NJ); Remote; USD 150,000 - 175,000; Full time

Job summary

An established industry leader in regenerative health is looking for a passionate Associate Director of GCP Quality Compliance. This pivotal role involves developing and executing a comprehensive audit infrastructure while building key vendor relationships. As a Clinical Quality leader, you will collaborate with executive leadership to ensure compliance with regulatory requirements and drive process improvements. Join a dedicated team focused on advancing better health outcomes for patients through innovation and collaboration. If you're ready to make a significant impact in clinical quality compliance, this is the perfect opportunity for you.

Qualifications

• 10 years of experience in the pharmaceutical industry; 8 years in GCP quality assurance.
• Strong knowledge of ICH GCP guidelines and relevant regulatory requirements.

Responsibilities

• Develop and maintain the annual audit plan and clinical vendor/supplier list.
• Conduct external audits of clinical investigator sites and vendors.
• Provide quality assurance oversight to ensure compliance with regulatory requirements.

Skills

Project Management

Quality Assurance

Regulatory Compliance

Process Improvement

Education

Bachelor's Degree in Scientific Discipline

Job description

This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$150,000.00/yr - $175,000.00/yr

Vice President - GxP Quality Recruitment at EPM Scientific

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.

Seniority level

Director

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing