gilead
Sr Manager, Quality Assurance
At a Glance
- Location
- Ireland - Cork, Ireland
- Work Regime
- hybrid
- Employment
- Full time
- Posted
- 2026-08-13
Key Requirements
Required Skills
Certifications
- GMP
Domain Knowledge
- Engineering
- Pharmaceutical
- Regulatory
- Supply Chain
Requirements
Demonstrated leadership experience in a QA role.
Operations knowledge.
Experience supporting regulatory inspections and audits.
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.
Responsibilities
Senior Manager, Quality Assurance Operations – Packaging
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.