QA Compliance Specialist

About Regeneron

Regeneron is a science-driven company dedicated to developing transformative medicines for serious illnesses worldwide. Joining our QA Compliance & Quality Systems team means contributing to a rapidly expanding organization committed to making a meaningful impact in patient care.

Location

Raheen, Limerick, Ireland.

Key Responsibilities

• Manage, review, and coordinate Change Control documentation to ensure adherence to company policies and regulatory standards.
• Provide quality oversight for Change Control procedures throughout all stages including initiation, assessment, execution, validation, and closure.
• Review and approve quality system documentation, such as Change Control archives, deviation investigations, CAPA documentation, risk assessments, SOPs, and work instructions.
• Collaborate cross-functionally with Manufacturing, Quality Control, Engineering, Validation, Supply Chain, MSAT, and other departments to evaluate and implement proposed changes appropriately.
• Ensure Change Controls are properly classified, documented, impact-assessed, and progressed within established deadlines.
• Support quality governance by tracking open records, escalating potential risks, and driving timely completion of corrective actions.
• Assist in generating and analyzing Quality System performance metrics to support management reviews and continuous improvements.
• Engage in investigations related to Change Controls, aiding in the identification and application of corrective and preventative measures as needed.
• Facilitate training development and delivery on Change Control and Quality System processes.
• Participate actively in initiatives aimed at improving the efficiency, compliance, and effectiveness of the Quality System.

Required Expertise and Skills

• Experience with Quality Systems including Change Controls, Deviations, CAPA, Audit Management, and Risk Management.
• Familiarity with current Good Manufacturing Practice (cGMP) regulations and expectations from regulatory bodies.
• Excellent organizational, communication, and stakeholder management skills enabling coordination across multiple teams.
• Desirable experience in biologics manufacturing.

Educational and Experience Requirements

• Degree in Science, Engineering, Pharmacy, Biotechnology, or related fields.
• Minimum 3 to 5 years of relevant experience in pharmaceutical, biotechnology, or regulated industries.
• Relevant professional experience may compensate educational prerequisites.

Additional Information

Regeneron fosters a workplace culture of inclusivity and equal opportunity. Accommodations are available for applicants with disabilities or chronic conditions where reasonable.

Salary Range: €46,200 to €75,400 annually, with compensation based on role level, skills, experience, and country-specific regulations. Benefits may include bonuses, equity, retirement programs, health and wellness benefits, paid time off, and family support.

This role requires onsite presence; please confirm location-specific onsite expectations with your recruiter or hiring manager.

Background checks including identity, right to work, and educational qualifications verification are part of the pre-employment process as per local laws.