QA Specialist III

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

• Support management of local Quality Management System (QMS) and assure that the implemented quality management system is always up to date
• Support the RP with the market release of the finished medicinal products
• Manage local Affiliate Change Controls, Deviations & CAPAs
• Support management of local recall activities and execution/participation in periodic mock product recall challenges
• Support or manage quality defects, falsified or counterfeit products and stock out as required
• Manage/Coordinate local complaints & falsified product investigations
• Manage product returns
• Support supplier management and supplier audits including those of distribution partners in Switzerland
• Support the drafting and renewing of quality agreements with internal manufacturers and/or external partners
• Support drafting of Quality Management Reviews
• Assess Annual Periodic Product Reviews (APQRs) in accordance with the Swiss marketing authorisation
• Support the verification of the authorizations of new customers/ existing customers
• Support inspections by the cantonal authorities and Swiss medic as well as corporate GDP/GMP audits
• Write and/or implement changes to controlled documents (e.g. SOPs and Quality Manual) as needed
• Work with 3PL/4PL, provide guidance on supply related issues
• Work with Product Supplier in relation to GDP activities, new packaging and artwork
• Support GPD&A with QA tasks as required

• Support the RP in maintaining the operating licences of Gilead Sciences Switzerland Sàrl for its medicinal products as well as for its gene therapy products in accordance with the Swiss Medicinal Products Licensing Ordinance (MPLO) and the Therapeutic Products Act (TPA) as well as the Transplantation Act
• Ensure that the requirements of all relevant national and international guidelines and internal specifications are met with regard to storage and distribution of products and that a compliant Quality System is in place at the Affiliate
• Decide whether or not a batch is released, independently of management
• Support Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, etc.
• Implement and maintain the SOP/guidance documentation system for Gilead Sciences Switzerland and review all SOPs depending on the subject matter as a reviewer of content and/or format
• Maintain up-to-date knowledge of all nationally applicable pharmaceutical legislation and disseminate this, explain and train employees where necessary
• Ensure that initial and continuous GDP training programmes are implemented and maintained, train and educate all personnel as regards applicable pharmaceutical legislation and its practical consequences for the company at a national and international level
• Decide on the final disposition of returned, rejected, recalled or falsified products, and approve any returns to saleable stock
• Ensure that suppliers and customers are approved and adequate records established and maintained. Approves and maintains an oversight of all subcontractors’ activities which may impact on GMP/GDP
• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
• Act as responsible contact person for internal GMP/GDP audits
• Ensure Quality Risk Management and conduct Quality Management Reviews
• Keep appropriate…