Senior Quality Assurance Leader - GMP & QMS Excellence

Chanelle Pharma; Loughrea; On-site; EUR 120,000 - 180,000; Full time

Job summary

Chanelle Pharma is seeking a Head of Quality Assurance to provide strategic and operational leadership of the QA function, ensuring GMP/GDP compliance and PQS effectiveness. The role oversees Quality Operations, QMS, Validation, and QP activities, with inspection readiness and ongoing improvement.

Based onsite five days in Loughrea, Co Galway, with a hybrid option after a 6-month probation; lead cross-functional teams across manufacturing, regulatory, and supply chain, and maintain batch release

Qualifications

• 10+ years of experience in pharmaceutical quality roles within a GMP environment.
• Minimum 5 years of leadership experience managing multidisciplinary quality teams.
• Experience in Quality Operations, Quality Systems, Validation, and regulatory inspections.
• Experience supporting or certifying commercial product batches.
• Proven track record leading complex quality improvement and compliance initiatives.
• Eligibility to act as Qualified Person (QP) within EU/EEA.

Responsibilities

• Lead and develop the QA organisation including QA Operations and QMS.
• Define and execute the Quality Strategy aligned with regulatory expectations.
• Oversee batch review, certification, release and quality risk management.
• Act as Primary QP or oversee QP activities and certify batches.
• Govern the QMS, document control and CAPA processes.
• Lead validation strategies for equipment, processes and cleaning.
• Ensure compliance with EU GMP, GDP, ICH, FDA and inspections readiness.
• Engage with stakeholders across Manufacturing, Regulatory, and Supply Chain.

Skills

Strategic Leadership

Regulatory & GMP Expertise

Quality Systems Management

Risk-Based Decision Making

People Leadership & Talent Development

Inspection and Audit Management

Continuous Improvement

Communication & Stakeholder Management

Education

Degree in Pharmacy / Pharmaceutical Science / QA

Eligibility to act as a Qualified Person (QP) within EU/EEA

Tools

eQMS

LIMS

Job description

Chanelle Pharma is seeking a Head of Quality Assurance to provide strategic and operational leadership of the QA function, ensuring GMP/GDP compliance and PQS effectiveness. The role oversees Quality Operations, QMS, Validation, and QP activities, with inspection readiness and ongoing improvement.

Based onsite five days in Loughrea, Co Galway, with a hybrid option after a 6-month probation; lead cross-functional teams across manufacturing, regulatory, and supply chain, and maintain batch release