Quality Assurance Operations Manager

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

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.

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.