Provide QA oversight for the planning, execution, and reporting of clinical trials for biologic programs.
Ensure compliance with ICH-GCP, FDA 21 CFR Parts 50/54/56/312, EMA regulations, and other international clinical trial requirements.
Support audit readiness of investigator sites, Clinical Research Organizations (CROs), and internal clinical teams.
Participate in vendor qualification and ongoing oversight of CROs, ensuring compliance with contractual and regulatory obligations.
Review and manage deviations, CAPAs, and change controls associated with Clinical activities.
Ensure quality documentation is complete, accurate, and compliant with corporate standards and global regulations.
Support continuous improvement initiatives across Clinical QA functions.
Provide quality input into regulatory submissions, including INDs, BLAs/MAAs, and safety updates.
Serve as a QA liaison between Clinical Operations, Regulatory Affairs, and external partners (CROs, Safety Vendors).
Support training and awareness of GCP and corporate quality policies across internal teams and contractors.
Facilitate effective communication between internal stakeholders and global regulatory authorities during audits and inspections.

Bachelor's degree with 9+ years of experience required OR
Master's degree and 7+ years of experience
PhD/JD and 5+ years of experience
MD/DO and 1+ years of experience may be considered
Relevant experience in Quality Assurance within Clinical Operations, preferably in biologics or biotechnology.
Strong knowledge of global regulatory requirements: ICH-GCP, EU GCP Directive/Regulation, FDA GCP regulations, and international GVP standards.
Experience with CRO vendor oversight, including audits and inspections.
Familiarity with electronic systems for clinical data (e.g., EDC, CTMS, Argus, ARISg, Veeva Vault).
Demonstrated success in managing quality issues, audits, and regulatory inspections.
Excellent communication, organizational, and interpersonal skills with the ability to influence and collaborate across functions and geographies

Associate Director, GCP Quality Assurance

Key skills