Sr Manager, Quality Assurance

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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 systemse.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

Bachelors 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 individuals 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.