Senior QA Validation Lead - Life Sciences Equipment

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 54,000 - 88,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Ireland is seeking a Senior QA Validation Specialist to join the Quality Assurance team. The role involves supervising end-to-end qualification processes for QC equipment, driving a quality culture and ensuring readiness for regulatory inspections.

You will coordinate validation activities, assess change controls and deviations, investigate issues, and collaborate with departments and vendors to deliver projects on time. On-site in Limerick with some travel.

Qualifications

• BS/BA in Engineering, Chemistry or Life Science.
• At least 5–8+ years’ proven experience within QA validation.
• SME in a highly regulated environment (pharma, biotech, medical devices) with internal and external regulatory audits.
• Strong background in site change controls, risk management and data integrity initiatives/programs.
• Expert knowledge of EU Annex 11 and FDA 21 CFR Part 11.

Responsibilities

• Supervising the end-to-end qualification process ensuring each piece of equipment fits for the intended use.
• Fostering and implementing a quality culture and other company manufacturing standards, policies and procedures.
• Scheduling, executing, reviewing and approving qualification activities.
• Assessing executed change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
• Investigating and troubleshooting problems and determining solutions or recommendations for changes and/or improvements.
• Reviewing, editing, and approving deviation notifications, deviation investigations and corrective actions, change controls, SOPs, reports and other documentation.
• Coordinating with other departments and outside contractors/vendors to complete validation tasks.
• Managing and driving projects.
• Supervising, providing direction and assigning work to less experienced full-time employees (e.g. validation specialists) and/or contingent workers to meet goals and deadlines.

Education

BS/BA in Engineering, Chemistry or Life Science

Job description

Regeneron Pharmaceuticals, Inc. in Ireland is seeking a Senior QA Validation Specialist to join the Quality Assurance team. The role involves supervising end-to-end qualification processes for QC equipment, driving a quality culture and ensuring readiness for regulatory inspections.

You will coordinate validation activities, assess change controls and deviations, investigate issues, and collaborate with departments and vendors to deliver projects on time. On-site in Limerick with some travel.