QA Operations Lead – GMP Quality & Compliance

R&D Partners; Limerick; On-site; EUR 80,000 - 110,000; Full time

Job summary

R&D Partners is seeking a QA Operations Team Manager to join a leading pharmaceutical company in Ireland. This role ensures the Quality Management System (QMS) is inspection-ready and compliant with EU, UK, and US GMP regulatory requirements. Lead, manage, and train the QA Operations and Document Control team while driving continuous improvement across operational quality systems.

Please note that to be considered for this role you must have the right to work in this location.

Qualifications

• Relevant science-based degree (e.g., Chemistry, Biology, Pharmacy).
• Minimum 6 years in Compliance and Quality Assurance within a GxP environment.

Responsibilities

• Provide leadership, guidance, and direction to the QA Operations and Document Control team for smooth daily operations and continuous improvement.
• Act as the primary point of contact for operational quality issues.
• Develop, maintain, and manage the site's internal audit/self-inspection schedule, ensuring timely execution and follow-up on findings.
• Approve and support investigations of significant quality events and CAPAs.
• Ensure batch records are reviewed promptly to facilitate timely batch release.
• Collaborate with operational teams to remediate potential issues and minimize impact.
• Act as SME for QMS and documentation processes during regulatory and third-party audits.
• Manage risks, quality events, deviations, investigations, change controls, and CAPAs to meet timelines.
• Coordinate preparation activities for regulatory inspections and provide support during inspections.
• Lead hiring, onboarding, mentoring, coaching, and performance management for the QA team.
• Develop and deliver GxP compliance training to operational areas.
• Instill a quality culture within the organization through active mentoring and training.

Skills

QA Leadership

Quality Assurance

GxP Compliance

Regulatory Audits

CAPA Management

Document Control

Risk Management

QMS

Cross-functional Collaboration

Education

Science-based degree

Tools

Microsoft Office

eQMS

Job description

R&D Partners is seeking a QA Operations Team Manager to join a leading pharmaceutical company in Ireland. This role ensures the Quality Management System (QMS) is inspection-ready and compliant with EU, UK, and US GMP regulatory requirements. Lead, manage, and train the QA Operations and Document Control team while driving continuous improvement across operational quality systems.

Please note that to be considered for this role you must have the right to work in this location.