Senior QA Specialist

We are seeking an experienced Senior Pharma QA Specialist to support quality and compliance activities within a highly regulated pharmaceutical/biotech environment. The ideal candidate will have strong GMP experience and a solid background in quality systems, investigations, CAPA, change control, risk management, and audit readiness.

• Provide QA oversight for GMP manufacturing and quality operations.
• Review and manage deviations, investigations, CAPAs, and change controls.
• Support quality risk assessments and compliance activities.
• Review GMP documentation, procedures, and quality records.
• Support validation, data integrity, and pharmaceutical quality system activities.
• Participate in internal and regulatory audits and inspection-readiness activities.
• Partner with Manufacturing, QC, Validation, and Engineering teams to resolve quality issues.
• Provide QA guidance on GMP and regulatory requirements.
• Support continuous improvement and quality compliance initiatives.
• Maintain accurate, inspection-ready quality documentation.

• 8 10+ years of QA experience in pharmaceutical, biotech, or a similarly regulated industry.
• Strong knowledge of GMP/cGMP and pharmaceutical quality systems.
• Hands-on experience with deviations, investigations, CAPA, change control, and risk assessments.
• Experience supporting audits, inspections, and regulatory compliance activities.
• Strong understanding of data integrity and quality documentation.
• Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related field preferred.
• Strong communication, problem-solving, documentation, and cross-functional collaboration skills.

• Must be available to travel to Ireland as required.
• Travel may involve approximately 2 weeks onsite per visit.