Principal QA Specialist

Initial Therapeutics, Inc.; Ireland; On-site; EUR 63,200 - 103,200; Full time

Job summary

Regeneron in Ireland seeks a Principal QA Specialist to join the QA Compliance & Quality Systems team. You will act as a SME for Change Control governance, oversee quality system processes, and drive improvements in compliance and product quality for life-changing medicines.

Based in Raheen, Limerick, this role offers chance to influence audits, regulatory inspections, CAPA activities, and cross-functional collaboration across Manufacturing, Regulatory Affairs, and MSAT to ensure data integrity

Qualifications

• Requires BSc/BEng in scientific discipline with 7+ years of relevant pharma experience.
• Strong knowledge of cGMP and regulatory expectations.
• Experience in Change Control, deviations, CAPA and risk management.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Serve as Quality Systems SME with primary responsibility for Change Control governance, oversight, and continuous improvement.
• Provide quality and compliance oversight of Quality System processes including Change Control, Deviations, CAPA, Audits, and Risk Management.
• Ensure Quality System records are managed in compliance with regulatory requirements and data integrity expectations.
• Review and approve Quality System documentation including Change Control records and CAPA plans.
• Lead or support governance forums and cross-functional meetings for Change Control and Quality System management.
• Monitor and communicate Quality System performance metrics and trends to drive process improvements.
• Perform quality review of high-impact changes for product quality and regulatory impacts.
• Support regulatory inspections and customer audits, including preparation and response to observations.
• Identify compliance risks and drive corrective actions with cross-functional teams.
• Collaborate with Manufacturing, QC, Engineering, MSAT, Supply Chain, Regulatory Affairs to integrate quality requirements.
• Lead and participate in continuous improvement initiatives for quality system performance.
• Support development and maintenance of Quality System procedures and training.

Skills

Change Control governance

Quality systems oversight

Regulatory compliance

Stakeholder management

Audits & inspections

Quality documentation review

Education

BSc/BEng in scientific discipline

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Principal QA Specialist to join our QA Compliance & Quality Systems team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location

• Raheen, Limerick

Responsibilities

• Serving as a Quality Systems Subject Matter Expert (SME) with primary responsibility for Change Control governance, oversight, and continuous improvement activities.
• Providing quality and compliance oversight of Quality System processes, including but not limited to Change Control, Deviations, CAPA's, Audits, Customer Complaints and Risk Management.
• Ensuring Quality System records are managed in compliance with regulatory requirements, company procedures, and data integrity expectations.
• Reviewing and approving Quality System documentation, including Change Control records, Deviation investigations, CAPA plans and Risk assessments.
• Leading or supporting governance forums, review boards, and cross-functional meetings associated with Change Control and Quality System management.
• Monitoring, analysing, and communicating Quality System performance metrics and trends, finding opportunities to improve process effectiveness, efficiency, and compliance.
• Performing quality review of complex, high-impact, and cross-functional changes to ensure appropriate assessment of product quality, regulatory, validation, and operational impacts.
• Supporting regulatory inspections and customer audits, including preparation activities, presentation of Quality System processes, and response development for observations or commitments.
• Identifying compliance risks, process gaps, and systemic issues within Quality Systems and leads or supports development and implementation of sustainable corrective actions.
• Collaborating with Manufacturing, Quality Control, Engineering, MSAT, Supply Chain, Validation, Regulatory Affairs, and other site functions to ensure quality and compliance requirements are effectively integrated into business processes.
• Leading and participating in continuous improvement initiatives aimed at enhancing Quality System performance, inspection readiness, and operational excellence.
• Supporting the development, implementation, and maintenance of Quality System procedures, policies, and training programs.

Environment and Physical Rhythms

• Experience working with Quality Systems, including one or more of the following: Change Controls, Deviations, CAPA's, Audit Management and Risk Management.
• Working knowledge of cGMP requirements and regulatory expectations.
• Strong organisational, communication, and stakeholder management skills, with the ability to effectively coordinate activities across multiple functional areas.
• Able to prioritise, re-prioritise as needed and adapt to change.
• Comfortable working in a fast-paced setting.

Requirements

• Requires BSc/BEng in scientific discipline or related field with 7+ years of relevant work experience in pharmaceutical or related industry.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Salary Range (annually) 63,200.00 - 103,200.00