QA Specialist III

Descripción del trabajo

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Key Responsibilities:

Quality Assurance Specialist III responsibilities include:
• 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 Swissmedic 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 Suppler in relation to GDP activities, new packaging and artwork
• Support GPD&A with QA tasks as required

Deputy Responsible Person responsibilities include:
• 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 records of any delegated duties.
• Ensure review and approval of Annual Product Quality Reports of all products.
• Ensure that product receipt, storage and delivery to customers are carried out in compliance with GMP & GDP and in line with the company policies and procedures.
• Ensure that for all manufacturers of drug products, that are imported and released, a manufacturing authorization from a state whose GMP control system is acknowledged by Switzerland is available or ensures that the medicinal product is manufactured according to the rules of GMP applicable in Switzerland.
• Ensure that suppliers and local service providers are audited on a regular basis.
• Ensure up to date organization charts, job descriptions, Curriculum Vitae and training records are available for personnel in the Affiliate involved in GDP activities.
• Ensure that the filing and archiving of batch release documentation, returned goods documentation and recalls is done according to the Gilead records retention policy and national requirements, whichever is longer/ more stringent.
• Ensure that complaints are handled according to both the local legislation and applicable company procedures.
• Define initial and ongoing training requirements for Affiliate and third party subcontracted personnel on GMP/GDP and on respective document management.
• Provide customer support for GMP/GDP-related enquiries and complaints
• Maintain, approve and sign Quality Agreements with EU Batch release (technical batch release) sites, local GMP/GDP service providers as well as ex-vivo cell therapy product apheresis and treatment centers in her/his function as RP.
• Communicate changes in quality information to project teams and senior management Initiating or contributing to local and / or global process improvements which have a significant impact on the business.

Education, Knowledge, Experience & Skills:

• A university degree in pharmacy, chemistry, biotechnology or other natural sciences
• Experience in an international environment and comprehensive knowledge of international and local quality systems as well as legal regulations and standards for pharmaceutical products and medical devices as well as proficiency in application of these requirements
• Experience in the quality assurance, preferably in the pharmaceutical industry or as deputy responsible person
• 6+ years of professional experience in QA/RA or 4+ years and an MSc or equivalent, of which at least 2 years of the experience is in the Swiss market
Proficiency in Quality system processes (Deviation, CAPA, Change Control, Complaints, Supplier Management etc)
Proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP, etc.
• Excellent influencing and negotiation skills
• High quality awareness, accurate, independent and reliable approach to work
• Ability to work in a team, work under pressure, flexibility and good communication skills
• Good organizational skills with well-structured ways of working
• Must be capable of leading small project teams
• Must have the ability to work and negotiate with a HA
• Ability to work on a number of projects with tight timelines
• Very good stylistically appropriate command of written and oral German and very good command of written and oral English, command of French and/or Italian would be an advantage

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.