Senior Quality & Compliance Leader – GMP & Audits

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

Job summary

Our client is a growing manufacturer serving pharmaceutical, biopharmaceutical, food and dairy sectors, seeking an experienced Quality Compliance Manager to lead site quality operations and drive excellence, compliance and continuous improvement.

This role will shape quality strategy, oversee the QMS, and act as the primary quality representative during audits, inspections and certifications, partnering with cross-functional teams to ensure GMP and regulatory standards are met.

Qualifications

• Degree in Chemistry, Pharmaceutical Science, Life Sciences, or a related discipline.
• Minimum 5 years' experience in pharmaceutical/biopharmaceutical or GMP-regulated manufacturing environments.
• 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.

Skills

QMS leadership

GMP expertise

ISO 9001

CAPA management

Audits & inspections

Cross-functional collaboration

Education

Chemistry / Pharmaceutical Science / Life Sciences degree

Job description

Our client is a growing manufacturer serving pharmaceutical, biopharmaceutical, food and dairy sectors, seeking an experienced Quality Compliance Manager to lead site quality operations and drive excellence, compliance and continuous improvement.

This role will shape quality strategy, oversee the QMS, and act as the primary quality representative during audits, inspections and certifications, partnering with cross-functional teams to ensure GMP and regulatory standards are met.