Sr 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
 

Key Responsibilities

Digital and Data support - QA Leadership & Governance

·       Lead a team of QA personnel supporting Manufacturing digital systems,e.g. MES, SAP, Serialisation including associated master data approval.

·       Represent Cork Quality at digital and data governance forums, ensuring appropriate oversight, escalation, and decision-making.

·       Partner cross-functionally to ensure alignment on system changes, priorities, and risk management.

Systems, Digital & Master Data Oversight

·       Lead a team of QA Subject Matter Experts and sustainment team providing local Quality support for SAP, MES, and associated Electronic Batch Record (EBR) systems.

·       Oversee a group of QA Specialists performing QA review and approval of SAP and MES master data related to Cork operations.

·       Responsible for the local QA support model for system sustainment, including incident management, deviations, CAPAs, and change controls.

Master Data Review & Approval 

·       Accountable for QA governance and approval of SAP and MES 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.

Project support

·       Provide QA local support for digital and system-related projects, ensuring appropriate validation and risk management.

·       Ensure compliance with GxP requirements and alignment with internal standards across project execution.

People Leadership & Capability Development

·       Lead, coach, and develop a high-performing QA team with strong digital and systems capability.

·       Promote a risk-based, collaborative quality culture and drive continuous improvement

Qualifications

Education

·       Bachelor’s degree in Science, Engineering or a related discipline.

Experience

·       Extensive experience in GMP Pharmaceutical industry.

·       Demonstrated leadership experience in a QA role.

·       Previous experience in multi-site global IT/Systems projects.

·       Operations knowledge.

·       Experience in supporting Regulatory inspections and audits.

Skills and Competencies

·       Expert Quality judgement in data integrity, systems compliance, and cross-functional risk management. 

·       Strong stakeholder management, influencing, and decision making capability at site and global level. 

·       Ability to lead in a complex, cross-functional environment.

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.