Make a difference in the lives of children and adults affected by rare diseases. As Director GCP Quality Management at Santhera Pharmaceuticals, you will play a critical role in supporting our clinical development program and ensuring compliance with global regulations.
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.
Requirements:
* 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.
We offer a multicultural, challenging, and innovative work environment. If your profile matches our requirements, we look forward to receiving your online application in English.