Lead and maintain GCP quality assurance programs to ensure compliance with FDA, EMA, and ICH regulatory requirements.
Provide ICH/GCP compliance guidance throughout the clinical development life cycle.
Plan, oversee, and conduct GCP audits including but not limited to qualification and re-qualification of vendors, internal process, site, TMF and other document audits.
Manage Quality and Compliance functional activities, including implementation and management of the QMS, inclusive of SOPs, Training and CAPAs.
Work closely with the Quality and Compliance staff and Operational Functions to provide strategic compliance advice and guidance.
Initiate the process of follow-up when suspicion of suspected scientific misconduct/serious non-compliance.
Review clinical and nonclinical documentation to ensure regulatory compliance, data integrity, and adherence to GCP standards.
Oversee quality events, deviations, and CAPA processes related to GCP activities.
Lead and support global health authority inspections.
Provide GCP guidance and training to cross-functional teams to promote a culture of quality and regulatory compliance.
Lead and develop Clinical QA staff while supporting continuous improvement of GCP and quality systems.
Supervisory responsibility of Quality & Compliance employees (where applicable).

Requires 10+ years of experience in GCP Quality Assurance within a CRO, biotechnology or pharmaceutical industry.
Bachelor’s degree in life sciences or a related scientific field (advanced degree preferred).
Demonstrated experience conducting and leading GCP audits across clinical sites, Internal Process audits, TMF audits and Vendor qualification audits.
Strong knowledge of FDA, EMA, and ICH regulations, including global GCP guidelines.
Experience supporting regulatory inspections and inspection readiness activities.
Strong leadership and communication skills with the ability to work cross-functionally across clinical and nonclinical teams.
Ability to interpret regulatory requirements and translate them into effective quality systems, procedures, and risk-based approaches.

Senior Director, Quality & Compliance

Key skills