Site Quality Manager

CareerWise Recruitment; Fermoy; On-site; EUR 90,000 - 130,000; Full time

Job summary

CareerWise Recruitment is assisting a well‑established manufacturer in seeking a senior Quality Leader for a busy production site. The role drives quality performance, regulatory compliance and continuous improvement across the site, with responsibility for the QMS, GMP and ISO 9001 standards.

You will lead audits, manage CAPAs and deviations, approve documentation and product releases, and support new specifications while developing staff capabilities in quality systems and training.

Qualifications

• Degree in Chemistry or related science.
• 5+ years in pharma/biopharma/GMP environments.
• Quality leadership experience.
• Strong GMP, ISO, validation, CAPA knowledge.
• Auditing and regulatory inspection experience.
• Excellent communication and leadership.

Responsibilities

• Lead and maintain the site QMS.
• Ensure GMP/ISO compliance.
• Manage audits and regulatory visits.
• Oversee CAPA, deviations, change controls.
• Approve quality documentation and product releases.
• Support development of specs and customer requirements.
• Lead quality training programmes.
• Drive continuous improvement and metrics.
• Provide quality support to customers and suppliers.

Skills

Quality leadership

QMS management

GMP knowledge

ISO standards

CAPA

Audits

Regulatory inspections

Product release

Documentation

Communication skills

Education

Degree in Chemistry

Job description

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

• 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.
• 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.