​We are seeking a proactive Director of Clinical Quality with expertise in clinical site audits, vendor audits, and audit plan development for sponsors. This pivotal role will ensure compliance and uphold rigorous quality standards across clinical trials.

Ability to travel globally as needed for audits, while being based in NJ office

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Key Responsibilities:

• Conduct clinical site audits and vendor audits to maintain compliance with regulatory requirements and internal standards.

• Develop and execute audit plans for sponsors, ensuring thorough coverage and timely completion.

• Document audit findings, prepare comprehensive reports, and collaborate with stakeholders to implement corrective actions.

• Maintain awareness of industry trends, regulatory updates, and best practices in clinical quality assurance.

Qualifications:

• Bachelor's degree in a relevant field; advanced degree preferred.

• Extensive experience in clinical quality assurance, with proficiency in site audits, vendor audits, and audit plan drafting.

• In-depth knowledge of regulatory requirements (e.g., FDA, EMA) and international standards (e.g., ICH GCP).

• Strong organizational skills, attention to detail, and ability to effectively communicate findings and recommendations.

• Prior inspection experience is advantageous, demonstrating readiness for regulatory inspections.