Manager, Quality Assurance

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
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Role Purpose
The Affiliate End-User Support Coordinator (SAP QM), within Global Product Distribution & Affiliates (GPD&A), serves as the primary point of contact for Quality Assurance users across Gilead affiliate organisations requiring support with SAP Quality Management processes. The role provides first-line support, practical guidance, troubleshooting, issue triage, testing support and training across quality master data, inspection management, batch release and related quality processes.
The coordinator partners with affiliate Quality teams, the SAP QM Support Team, IT and other relevant stakeholders to support compliant, consistent and effective use of SAP QM and other GPD&A quality systems. The role helps translate business process requirements into practical system use, supports system changes and enhancements, and strengthens adoption through clear documentation, user guidance and structured training.
Key Responsibilities
· Serve as the primary support contact for Quality Assurance personnel and business users requiring assistance with SAP QM processes.
· Provide guidance on material master setup and maintenance for QM-relevant materials, quality master data, inspection plans, inspection lots, batch release and Usage Decisions, quality notifications, batch status management, shelf-life extension, retest or next inspection date processes, and general SAP QM navigation and transaction use.
· Respond to user questions on how to perform SAP QM transactions, applicable process requirements, procedural compliance and approved business processes.
· Direct users to applicable SOPs, Work Instructions, business guidance documents, training materials and support resources.
· Support SAP security and access activities, including helping users identify appropriate SAP QM roles, explaining role capabilities and limitations, guiding users through access request processes and supporting new-user onboarding.
· Investigate, assess and triage reported SAP QM issues by gathering relevant information, differentiating user error, training need, data issue and potential system defect, reproducing issues where possible, assessing business impact and documenting recommended next steps.
· Escalate unresolved issues to the SAP QM Support Team or IT support teams and act as a liaison between business users and technical teams throughout the incident and resolution lifecycle.
· Coordinate with system and process owners to diagnose root causes, clarify business requirements, communicate status updates and support implementation of corrective actions.
· Support system lifecycle activities for SAP QM and connected quality systems, including requirements clarification, impact assessment, change control, access considerations, data readiness, testing, deployment readiness and post-implementation support.
· Execute User Acceptance Testing and regression testing for system fixes and enhancements, document test evidence and results, and support validation activities in accordance with applicable quality and compliance requirements.
· Maintain and improve user guidance, knowledge articles, process documentation and training materials so that approved system processes are clear, accessible and consistently applied.
· Prepare and deliver process and system training to support effective implementation and sustained adoption of quality and process improvements.
· Identify recurring user issues, system pain points and process inefficiencies, and recommend improvements to processes, system configuration, training, support services and documentation.
· Participate in support team meetings, process reviews, system change initiatives and continuous improvement activities.
· Promote standardised and compliant use of SAP QM across global affiliate organisations while recognising approved local business and regulatory requirements.
· Although the primary focus of the role is SAP QM, the position also serves as a key support resource for other GPD&A systems that enable quality, distribution, and affiliate operations. The coordinator develops and maintains knowledge across the GPD&A systems portfolio to ensure consistent support, effective user adoption, and alignment with evolving business needs.
Knowledge, Experience & Behaviours
• Bachelor's degree in Life Sciences, Quality, Information Systems, Engineering, Supply Chain or a related discipline. An equivalent combination of education and relevant industry experience may be considered.
• 6+ years of experience in the pharmaceutical, biotechnology, medical device or other regulated manufacturing environment.
• Experience supporting Quality Assurance operations and business processes within a GxP-regulated environment.
• Strong knowledge of SAP Quality Management (SAP QM) and associated quality processes, including batch management, inspection management, quality master data and disposition activities.
• Knowledge of computerised system compliance requirements, including 21 CFR Part 11, change control, CAPA, deviation management and validation principles.
• Demonstrated experience supporting business systems, system enhancements, implementations, testing activities and end-user adoption initiatives.
• Understanding of the relationship between business processes, system configuration, master data, user roles and compliance requirements.
• Experience working with cross-functional stakeholders including Quality, IT, Supply Chain and Business Operations teams.
• Strong analytical, problem-solving and troubleshooting skills with the ability to assess issues, identify root causes and recommend practical solutions.
• Excellent communication, facilitation and training skills with the ability to translate technical concepts into clear business language.
• Strong organisational skills with the ability to manage competing priorities and operate effectively in a global environment.
• Demonstrated customer-focused mindset with a commitment to continuous improvement and service excellence.
• Experience supporting global affiliates, multiple sites or international business operations is preferred.
• SAP S/4HANA Quality Management certification or equivalent experience is essential.
Gilead Core Values
· Integrity (always doing the right thing)
· Teamwork (collaborating in good faith)
· Excellence (working at a high level of commitment and capability)
· Accountability (taking personal responsibility)
· Inclusion (encouraging diversity)
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 origi