Senior Site Quality Leader – GMP/ISO, Audits & CI

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

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.