An exciting Pharma company is looking for an experienced Quality leader to join as they expand their site and operations.
Key responsibilities include:
- Qualify, evaluate and supervise suppliers, logistics service providers and CMOs
- Conduct audits and support inspections at suppliers, logistics service providers and CMOs
- Establish appropriate Quality Agreements
- Establish appropriate Quality Oversight principles for the contracted services
- Host customer audits
- Review of quality related documentation issued by CMOs
- Assess and coordinate release activities with release sites
- Ensure quality and regulatory compliance to the registered dossier, including and not limited to change management
- Maintain Quality Management Systems and ensure compliance with the regulatory applicable local and global requirements
- Prepare, review and maintain SOPs
- Manage deviations, CAPAs, changes and complaints
- Maintain and improve the quality training system
- Validate systems and processes
- Perform internal audits
- Communicate with authorities within the scope of a Responsible Person
Key requirements include:
- University diploma / state examination in pharmacy or other natural sciences
- Proven track record of 5+ years in pharmaceutical industry internationally with at least 4 years GMP/GDP experience in a quality function, preferably as Responsible Person
- Sound knowledge of GMP/GDP, quality system requirements, as well as biopharmaceutical, Swiss and international (EU, US) pharmaceutical regulations
- Ideally trained as auditor and experience in supplier and CMO oversight and audits
- Fluent in both English and German
