Quality Assurance Operations Manager

HRM Search Partners; Sligo; On-site; EUR 90,000 - 120,000; Full time

Job summary

HRM Search Partners is seeking an experienced QA Operations Manager for our client in Sligo to lead day-to-day Quality Assurance oversight of GMP manufacturing operations.

The role focuses on ensuring products are manufactured, tested, packaged, stored and released in compliance with regulatory requirements and established quality systems. A hands-on leadership approach will drive QA across Manufacturing, Packaging, Warehouse, Engineering, Validation and QC.

Qualifications

• Extensive QA leadership experience in GMP manufacturing.
• Strong knowledge of EU GMP, EMA, ICH, USP, Ph. Eur standards.
• Proven ability to lead deviations, CAPAs and change controls.

Responsibilities

• Lead day-to-day QA operations, providing real-time QA support to Manufacturing, QC and Compliance.
• Maintain QA presence on the manufacturing floor to support decision-making and risk escalation.
• Oversee deviations, CAPAs, change controls and regulatory inspections readiness.
• Lead quality risk assessments across manufacturing, facilities and materials.
• Support audits, reviews of batch records and SOPs, and continuous improvement initiatives.
• Coach and develop the QA team and coordinate with cross-functional partners.

Skills

GMP Quality Oversight

People Management

Regulatory Inspections

Risk Assessment

QA Process Improvement

Cross-functional Collaboration

Education

Advanced degree in Biological Sciences or Pharmaceutical Sciences

Tools

QA Systems (e.g., TrackWise)

Job description

Our client is an established international organisation operating within the pharmaceutical and life sciences sector. With a strong focus on manufacturing excellence, product quality and regulatory compliance, the business operates in a highly regulated environment and is committed to maintaining robust quality systems and operational standards.

The business is seeking to appoint an experienced QA Operations Manager to lead the day-to-day Quality Assurance oversight of GMP manufacturing operations at its Sligo site.

This is a hands-on operational leadership role with responsibility for ensuring products are manufactured, tested, packaged, stored and released in compliance with regulatory requirements and established quality systems.

The successful candidate will provide Quality leadership across Manufacturing, Packaging, Warehouse, Engineering, Validation and QC, ensuring effective QA oversight, timely management of quality issues and a proactive approach to risk management and continuous improvement.

The Role

• Lead day-to-day Quality Assurance operations, providing real-time Quality support to Manufacturing, QC and Compliance teams.
• Maintain a strong QA presence on the manufacturing floor, supporting effective decision-making and timely escalation of quality risks.
• Ensure appropriate Quality oversight of critical manufacturing processes, including line clearances, material movements, sampling, cleaning and environmental controls.
• Oversee deviation management, CAPAs and quality investigations, ensuring effective root-cause analysis and timely resolution.
• Lead and support quality risk assessments relating to manufacturing operations, process deviations, contamination control, facilities, equipment and materials.
• Support regulatory audits and inspections, ensuring ongoing inspection readiness and compliance with GMP requirements.
• Manage the review and maintenance of GMP documentation, including batch records and Standard Operating Procedures (SOPs).
• Identify procedural gaps, compliance risks and opportunities to strengthen quality systems and operational processes.
• Support operational readiness for new products, process changes, facility upgrades and manufacturing activities.
• Lead, coach and develop the QA team, building technical capability, accountability and effective risk-based decision-making.
• Work closely with Manufacturing, QC, Engineering, Validation and wider cross-functional stakeholders to resolve quality issues and support operational priorities.
• Collaborate with suppliers, vendors and contractors to maintain appropriate quality and compliance standards.
• Drive continuous improvement initiatives and support wider departmental objectives.

Key Requirements

• Minimum 6-8 years' relevant experience within the pharmaceutical or biotechnology industry.
• At least 2-3 years' experience managing GMP Quality Operations activities.
• Previous leadership experience within a GMP-regulated biologics, vaccines or sterile manufacturing environment.
• Demonstrable experience leading and developing QA teams, with strong coaching and people management capability.
• Strong working knowledge of EU GMP requirements, regulatory inspections and applicable standards, including EMA, ICH, USP and Ph. Eur.
• Experience managing deviations, CAPAs, change controls, batch record reviews and inspection readiness activities.
• Previous experience interfacing with regulatory authorities and managing regulatory inspections.
• Strong understanding of quality risk management, manufacturing compliance and Pharmaceutical Quality Systems.
• Demonstrated ability to resolve complex quality and technical issues and implement effective, sustainable improvements.
• Experience improving QA processes and supporting digital transformation within quality systems.
• Strong communication, influencing and cross-functional stakeholder management skills.
• Advanced degree in Biological Sciences, Pharmaceutical Sciences or a related discipline.
• Ability to manage competing priorities, make sound risk-based decisions and deliver results in a fast-paced manufacturing environment.