Quality Systems Lead - QMS, CAPA & Audits

Metric Bio; Dublin; On-site; EUR 65,000 - 95,000; Full time

Job summary

Metric Bio is seeking a Quality Specialist to provide robust quality oversight across the CDMO's QMS, projects, and laboratory operations. The role drives compliance, data integrity, and continuous improvement within a regulated environment.

You will lead document control, deviations, CAPAs, audits, and training, ensuring client expectations and regulatory requirements are met. A strong QA mindset and cross-functional collaboration are essential.

Qualifications

• Experience in a regulated pharma/lab environment.
• Knowledge of GMP/GDP and data integrity.
• Auditing and CAPA experience.

Responsibilities

• Provide leadership and governance of QMS to ensure compliance and continuous improvement.
• Lead audit readiness and ensure closure of audit actions.
• Oversee quality oversight of projects and laboratory activities.
• Ensure ALCOA+ data integrity and regulatory compliance.

Skills

QMS

GMP/GDP

ALCOA+

CAPA

Audits

Data integrity

Investigations

Change control

Training management

Documentation review

Communication

Education

Science/QA degree

Tools

eQMS

Job description

Metric Bio is seeking a Quality Specialist to provide robust quality oversight across the CDMO's QMS, projects, and laboratory operations. The role drives compliance, data integrity, and continuous improvement within a regulated environment.

You will lead document control, deviations, CAPAs, audits, and training, ensuring client expectations and regulatory requirements are met. A strong QA mindset and cross-functional collaboration are essential.