Director, Clinical Quality Assurance & Audit Strategy

Green Key Resources LLC; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Green Key Resources LLC is partnering with a global biopharmaceutical organization to hire a Director of Clinical Quality Assurance. This leader will develop and drive the quality strategy across clinical development programs, ensuring alignment with GCP and global regulations.

You will oversee GCP audits, support regulatory inspections, mentor QA staff, and collaborate with Clinical Operations, Regulatory Affairs, and Development teams to mitigate risk and improve quality systems.

Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline.
• Advanced degree in a related field preferred.
• Minimum 10 years of experience in clinical research, clinical operations, QA, or related function.
• Extensive GCP auditing experience including routine, complex, and for-cause audits.
• Strong experience supporting regulatory inspections.
• Experience in site monitoring or clinical study management a plus.

Responsibilities

• Lead the design, implementation, and execution of Clinical Quality Assurance strategy across clinical development activities.
• Conduct and oversee GCP audits (study site, vendor, clinical document, internal process audits).
• Support and facilitate regulatory authority inspections and inspection readiness activities across global clinical programs.
• Provide quality oversight to ensure compliance with regulatory requirements, guidelines, and internal standards.
• Partner cross-functionally with Clinical Operations, Development, Regulatory Affairs, and other stakeholders to identify and mitigate quality risks.
• Contribute to the development and enhancement of quality systems, processes, and continuous improvement initiatives.
• Support growth and development of quality team capabilities through training, mentoring, and knowledge-sharing.
• Potentially provide direct management and leadership of Clinical Quality Assurance personnel.

Skills

Analytical skills

Problem-solving

Technical writing

Education

Bachelor's degree in scientific/healthcare field

Advanced degree preferred

Job description

Green Key Resources LLC is partnering with a global biopharmaceutical organization to hire a Director of Clinical Quality Assurance. This leader will develop and drive the quality strategy across clinical development programs, ensuring alignment with GCP and global regulations.

You will oversee GCP audits, support regulatory inspections, mentor QA staff, and collaborate with Clinical Operations, Regulatory Affairs, and Development teams to mitigate risk and improve quality systems.