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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 & Experience
• Extensive experience in the GMP pharmaceutical industry and a Bachelor's degree in Science, Engineering, or a related discipline.
• Extensive experience in the GMP pharmaceutical industry and a Master's degree in Science, Engineering, or a related discipline.
• Demonstrated leadership experience in a QA role.
• Operations knowledge.
• Experience supporting regulatory inspections and audits.
Skills & Competencies
• Expert quality judgement in compliance and cross-functional risk management.
• Strong stakeholder management, influencing, and decision-making capability at both site and global level.
• Ability to lead in a complex, cross-functional environment.
Additional Role Accountability 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.
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.
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