Quality Management Specialist at Santhera Pharmaceuticals
Publication date:
22 February 2025Workload:
100%Contract type:
Unlimited employment- Place of work:Pratteln
Job summary
Santhera Pharmaceuticals seeks a Director GCP Quality Management. Join a dynamic team focused on rare neuromuscular diseases.
Tasks
- Lead and execute risk-based GCP audit programs effectively.
- Provide GCP expertise and ensure compliance in clinical programs.
- Manage audits and develop CAPAs for timely resolution of issues.
Skills
- Bachelor's degree with 5-7 years in pharmaceutical GCP quality.
- Strong communication and stakeholder management abilities.
- Organized, detail-oriented with strategic problem-solving skills.
Summary from the original job ad
Is this helpful?
Director GCP Quality Management Location: Pratteln, Switzerland (Hybrid) 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.
- 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
- 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.
- Strong communication and stakeholder management skills.
- Ability to work both independently and within a matrix organization.
- Strategic mindset with strong problem-solving abilities.
- Organized and detail-oriented, with excellent planning capabilities.
- Adaptability to changing priorities and deadlines.
