Senior GMP QA Operations Leader

HRM Search Partners; Sligo; On-site; EUR 80,000 - 110,000; Full time

Job summary

HRM Search Partners client, an international organisation in pharma/biotech, seeks an experienced QA Operations Manager to lead day-to-day QA oversight of GMP manufacturing at the Sligo site.

Responsibilities include real-time QA support to Manufacturing, QC and Compliance; on-floor QA presence; deviation and CAPA oversight; risk assessments; regulatory audit readiness; and continuous improvement across quality systems and processes.

Qualifications

• Minimum 6-8 years of relevant pharma/biotech experience.

Responsibilities

• Lead day-to-day Quality Assurance operations, providing real-time QA support to Manufacturing, QC and Compliance teams.
• Maintain QA presence on the manufacturing floor, supporting decision-making and timely escalation of quality risks.
• Ensure QA oversight of critical manufacturing processes including line clearances, material movements, sampling, cleaning and environmental controls.
• Oversee deviations, CAPAs and quality investigations with root-cause analysis and timely resolution.
• Lead and support quality risk assessments relating to operations, deviations, contamination control, facilities, equipment and materials.
• Support regulatory audits/inspections ensuring readiness and GMP compliance.
• Manage GMP documentation reviews including batch records and SOPs.
• Identify procedural gaps and opportunities to strengthen quality systems and processes.
• Support readiness for new products, process changes, facility upgrades and manufacturing activities.
• Lead, coach and develop QA team with risk-based decision-making.
• Collaborate with cross-functional stakeholders to resolve quality issues and support priorities.
• Engage with suppliers/contractors to maintain quality standards and compliance.
• Drive continuous improvement initiatives across quality systems.

Skills

QA Operations

People Management

GMP Compliance

Regulatory Inspections

Quality Risk Mgmt

Cross-Functional

Communication

Education

Advanced degree in Biological/Pharmaceutical Sciences

Job description

HRM Search Partners client, an international organisation in pharma/biotech, seeks an experienced QA Operations Manager to lead day-to-day QA oversight of GMP manufacturing at the Sligo site.

Responsibilities include real-time QA support to Manufacturing, QC and Compliance; on-floor QA presence; deviation and CAPA oversight; risk assessments; regulatory audit readiness; and continuous improvement across quality systems and processes.