Director, Clinical and Safety Quality

The Clinical & Safety Quality Director is responsible for establishing, leading, and maintaining an effective Clinical and Pharmacovigilance Quality Management System (QMS) to ensure GCP and GVP compliance for all sponsored clinical development activities and commercial products.

The role provides strategic quality oversight of clinical trials and safety activities across a development portfolio mainly spanning Phase II to Phase IV, ensuring inspection readiness and continuous improvement while enabling timely and compliant execution of clinical programs.

Principal Accountabilities

• Define, implement, and maintain the Clinical and Safety Quality strategy aligned with global regulatory requirements (ICH-GCP, EU CTR, GVP Modules, FDA regulations).
• Ensure effective oversight of Sponsor responsibilities for outsourced clinical and pharmacovigilance activities conducted by CROs, vendors, and partners.
• Lead the development, maintenance, and ...