Director GCP Quality Management

Santhera Pharmaceuticals

Pratteln, Switzerland

Scope of Work

We are looking for a Director GCP Quality Management to play a critical role in supporting our clinical development program and ensuring compliance with global regulations. Reporting to the Head of Quality Management, you will be a key driver in shaping and maintaining our quality culture. In this pivotal role, you will lead GCP Quality Management activities, ensuring clinical development programs are conducted in line with regulatory requirements. You will collaborate across teams, provide expert guidance, and play a leading role in audits, risk management, and inspection readiness.

Key Responsibilities

Design, plan, and execute risk-based GCP audit programs (internal and external);
Provide GCP expertise to project teams and ensure Quality Management input in clinical programs;
Lead or contribute to Quality Risk Management activities for clinical trials;
Manage and conduct audits of internal processes, external vendors, and investigator sites to ensure compliance and identify risks;
Oversee the development of CAPAs (Corrective and Preventive Actions) and ensure timely resolution of GCP issues;
Establish effective communication of audit/inspection outcomes and drive continuous improvement;
Align activities with other Quality Management functions (e.g., GVP, GMP) to ensure a cohesive approach;
Stay ahead of emerging regulations and ensure knowledge transfer within the organization.

Required Qualifications & Experience

Bachelor’s degree (or higher) in a relevant field;
5-7 years of experience in the pharmaceutical or life sciences industry, with a strong focus on GCP Quality Management;
In-depth knowledge of FDA, EU, and ICH guidelines for clinical research;
Proven track record managing GCP audits, health authority inspections, and inspection readiness;
Experience in Quality Risk Management for clinical trials and implementation of quality plans;
Knowledge of pharmacovigilance regulations is a plus;
Excellent interpersonal and communication skills with the ability to work in a fast-paced, collaborative environment;
Ability to travel up to 30%;
Fluency in English (written and spoken) is required.