Director, Clinical Quality Assurance

Green Key Resources; 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

A global biopharmaceutical organization, is seeking a Director, Clinical Quality Assurance to provide leadership and oversight of Clinical Quality Assurance activities across clinical development programs. This individual will be responsible for driving quality strategy, supporting audit and inspection readiness, and ensuring compliance with global regulatory requirements and Good Clinical Practice (GCP) standards.

Key Responsibilities

• Lead the design, implementation, and execution of Clinical Quality Assurance strategy across clinical development activities.
• Conduct and oversee GCP audits, including study site, vendor, clinical document, and internal process audits.
• Support and facilitate regulatory authority inspections and inspection readiness activities across global clinical programs.
• Provide quality oversight and guidance to ensure compliance with applicable regulatory requirements, industry guidelines, and internal quality 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 the growth and development of quality team capabilities through training, mentoring, and knowledge-sharing initiatives.
• Potentially provide direct management and leadership of Clinical Quality Assurance personnel.

Key Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline; advanced degree preferred.
• Minimum of 10 years of experience in clinical research, clinical operations, quality assurance, or a related function.
• Extensive GCP auditing experience including conducting routine, complex, and for-cause audits independently.
• Strong experience supporting and managing regulatory inspections.
• Strong analytical, problem-solving, and technical writing skills.
• Prior experience in site monitoring and/or clinical study management would be a plus.