Quality System Manager

CareerWise Recruitment; Ireland; On-site; EUR 90,000 - 120,000; Full time

Job summary

CareerWise Recruitment in Ireland is seeking a senior Quality Manager for a Cork-based pharmaceutical manufacturer. The role leads the site QMS, ensuring GMP compliance and driving continuous improvement across operations.

You will oversee audits, regulatory inspections, CAPAs, deviations and product releases, and lead quality training while collaborating with customers, suppliers and commercial teams. Extensive leadership and chemistry background required.

Qualifications

• Proven leadership in quality at GMP/manufacturing sites.
• Strong knowledge of GMP/ISO standards and validation.
• Excellent communication and problem-solving abilities.

Responsibilities

• Lead and maintain the site Quality Management System (QMS).
• Ensure GMP, ISO 9001 and other regulatory standards are met.
• Manage audits, customer inspections and regulatory visits.
• Oversee CAPAs, deviations, change controls and quality investigations.
• Approve quality documentation, validation activities and product releases.
• Support development of new product specifications and customer requirements.
• Lead quality training programmes and ensure site-wide compliance.
• Drive continuous improvement metrics and quality performance.
• Provide quality support to customers, suppliers and commercial teams.

Skills

Quality leadership

Audits & inspections

Regulatory compliance

Problem solving

Education

Chemistry degree

Job description

Are you an experienced Quality Manager with a strong chemistry background and expertise in GMP-regulated manufacturing?

Our Cork-based client is a well-established manufacturer supplying the pharma, biopharma, food and dairy sectors. This is a senior leadership role with responsibility for driving quality performance, regulatory compliance, and continuous improvement across a busy production site.

THE ROLE:

• Lead and maintain the site Quality Management System (QMS).
• Ensure compliance with GMP, ISO 9001 and other regulatory standards.
• Manage audits, customer inspections and regulatory visits.
• Oversee CAPAs, deviations, change controls and quality investigations.
• Approve quality documentation, validation activities and product releases.
• Support development of new product specifications and customer requirements.
• Lead quality training programmes and ensure compliance across the site.
• Drive continuous improvement initiatives and quality performance metrics.
• Provide quality support to customers, suppliers and commercial teams.

REQUIREMENTS:

• Degree qualification in Chemistry or related scientific discipline.
• 5+ years' experience in pharmaceutical, biopharma or GMP manufacturing environments.
• Previous quality leadership or management experience.
• Strong knowledge of GMP, ISO standards, validation, CAPA and quality systems.
• Proven experience managing audits and regulatory inspections.
• Excellent communication, leadership and problem-solving skills.