Sr Manager, Quality Assurance

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About the role

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   Senior Manager, Quality Assurance Operations – Packaging Role Summary The Senior Manager, Quality Assurance Operations – Packaging is a key leadership role within the Quality Assurance Operations organisation at the Cork site. Reporting to the Director, Operations Quality Assurance, the role leads a team responsible for quality oversight of packaging operations, ensuring compliance with GMP requirements, regulatory expectations, and product labelling requirements. The role leads a team that works closely with Packaging Operations and associated functions to support the compliant and timely resolution of deviations, provide quality presence and guidance through routine on-the-floor engagement, and drive continuous improvement and higher quality standards across packaging operations. The role is accountable for maintaining inspection readiness, data integrity, and quality system compliance across packaging operations and associated digital systems, including SAP, MES, and Electronic Batch Records (EBR). Working collaboratively with Packaging Operations, Labelling Operations, Engineering, Technical Services, Validation, QC, Supply Chain, IT, and global functions, the Senior Manager ensures the compliant and uninterrupted supply of product to patients while driving quality excellence and continuous improvement across the packaging process. Key Responsibilities QA Leadership & Governance • Lead a team of QA personnel supporting Packaging Operations at GSIUC Cork, including batch record review, artwork review and approval, deviation management, and CAPAs. • Responsible for the local QA Packaging support model for packaging line support and issue resolution, supporting Packaging Operations and ensuring delivery of quality objectives, performance expectations, and compliance standards. • Drive the identification, assessment, and mitigation of quality and compliance risks associated with packaging activities. • Oversee the Functional Service Provider team of QA Specialists supporting Packaging Operations. People Leadership & Capability Development • Lead, coach, and develop a high-performing QA team with strong compliance and technical understanding. • Promote a risk-based, collaborative quality culture and drive continuous improvement. Master Data Review & Approval • Accountable for QA governance and approval of SAP, MES, and Serialisation master data relevant to Cork site operations. • Ensure alignment with global data standards and procedures. • Partner with global Master Data teams to prioritise activities and resolve complex or high-risk issues. Qualifications Education &

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