Senior Quality Leader - GMP, ISO, CAPA & Audits

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

Job summary

Our client, a well-established manufacturer serving pharma, biopharma, food and dairy sectors, seeks a Senior Quality Leader to drive quality performance, regulatory compliance and continuous improvement across a busy production site.

You will own the QMS, lead audits and inspections, oversee CAPAs and deviations, approve validation and product releases, and mentor quality teams while collaborating with customers, suppliers and commercial teams.

Qualifications

• Degree in Chemistry or related scientific discipline.
• 5+ years' experience in pharma/biopharma or GMP manufacturing.
• Leadership or management experience in quality.
• Strong knowledge of GMP, ISO standards, validation, CAPA and quality systems.

Responsibilities

• 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.

Skills

Quality leadership

GMP compliance

ISO 9001

CAPA & deviations

Audits & inspections

Regulatory affairs

Quality systems

Document control

Team leadership

Education

Degree in Chemistry or related scientific discipline

Job description

Our client, a well-established manufacturer serving pharma, biopharma, food and dairy sectors, seeks a Senior Quality Leader to drive quality performance, regulatory compliance and continuous improvement across a busy production site.

You will own the QMS, lead audits and inspections, oversee CAPAs and deviations, approve validation and product releases, and mentor quality teams while collaborating with customers, suppliers and commercial teams.