Quality Management Specialist at Santhera Pharmaceuticals
Santhera Pharmaceuticals (Schweiz) AG
Date de publication :
22 février 2025Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Pratteln
Résumé de l'emploi
Santhera Pharmaceuticals, entreprise suisse spécialisée, recherche un Directeur GCP. Rejoignez une équipe engagée à traiter des maladies rares.
Tâches
- Concevoir et exécuter des programmes d'audit GCP basés sur les risques.
- Fournir une expertise GCP aux équipes projets et garantir la qualité.
- Gérer les audits internes et externes pour assurer la conformité.
Compétences
- Diplôme pertinent et 5-7 ans d'expérience en qualité GCP.
- Excellentes compétences en communication et gestion des parties prenantes.
- Capacité à travailler de manière autonome et en équipe.
Résumé de l'annonce originale
Est-ce utile ?
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.
