Quality Compliance Manager (GMP)

Careerwise Recruitment; Fermoy; On-site; EUR 90,000 - 120,000; Full time

Job summary

Careerwise Recruitment is assisting a rapidly growing pharma manufacturer in Ireland to appoint an experienced Head of Quality & Compliance. You will lead the site's QMS, drive regulatory excellence, and act as primary quality representative during audits.

In this senior role you will partner with senior leadership to shape quality strategy, ensure GMP/ISO 9001 compliance, and deliver improvements across manufacturing, validation, documentation, and release activities.

Qualifications

• Degree qualified in Chemistry, Pharmaceutical Science, Life Sciences, or related discipline.
• Minimum 5 years' experience in pharmaceutical, biopharmaceutical, or GMP-regulated manufacturing.
• Experience leading quality teams and quality systems.

Responsibilities

• Lead and continuously improve the site's Quality Management System (QMS).
• Ensure ongoing compliance with GMP, ISO 9001, customer requirements, and regulatory standards.
• Act as site lead for regulatory inspections, customer audits, and certification assessments.
• Drive management of CAPAs, deviations, non-conformances, change controls, and root cause investigations.
• Review and approve quality documentation, validation activities, specifications, and product release activities.
• Partner with production, engineering, technical, and commercial teams to support new products and customer requirements.

Skills

Leadership

Quality management

Regulatory compliance

CAPA management

Audit readiness

Education

Chemistry / Pharmaceutical Science / Life Sciences degree

Job description

Pharma, Biopharma & GMP Manufacturing

Our client is a highly successful and growing manufacturer serving leading customers across the pharmaceutical, biopharmaceutical, food and dairy sectors. Due to continued growth, they are seeking an experienced Quality Compliance Manager to lead site quality operations and drive a culture of excellence, compliance, and continuous improvement.

This is a key leadership position offering the opportunity to shape quality strategy, influence site performance, and play a critical role in maintaining the highest standards of product quality and regulatory compliance.

As Head of Quality & Compliance, you will lead the site's Quality Management System and serve as the primary quality representative during customer, regulatory, and certification audits. Working closely with senior leadership and cross-functional teams, you will ensure the business continues to meet and exceed GMP and quality standards while supporting future growth and innovation.

Key Responsibilities

• Lead and continuously improve the site's Quality Management System (QMS).
• Ensure ongoing compliance with GMP, ISO 9001, customer requirements, and relevant regulatory standards.
• Act as site lead for regulatory inspections, customer audits, and certification assessments.
• Drive effective management of CAPAs, deviations, non-conformances, change controls, and root cause investigations.
• Review and approve quality documentation, validation activities, specifications, and product release activities.
• Partner with production, engineering, technical, and commercial teams to support new products and customer requirements.

About You

You are a quality-focused leader with a proven track record within regulated manufacturing environments. You thrive in a fast-paced setting, enjoy leading teams, and are passionate about driving compliance and quality excellence.

Requirements

• Degree qualified in Chemistry, Pharmaceutical Science, Life Sciences, or a related discipline.
• Minimum 5 years' experience within pharmaceutical, biopharmaceutical, or GMP-regulated manufacturing environments.
• Previous experience leading quality teams and quality systems.

Why Apply?

• Senior leadership role with genuine influence across the business.
• Opportunity to work with customers in the pharma, biopharma, food, and dairy sectors.
• Highly visible position with responsibility for quality strategy and regulatory compliance.
• Collaborative and supportive leadership team.
• Excellent opportunity for career progression and professional growth.

Candidates must be authorised to work in Ireland at the time of application. Sponsorship is not available for this role.