Sr Manager, Quality Assurance

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.