Senior Quality Compliance Specialist

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

When & where:

• Location: Raheen, Limerick.

What you'll do:

• Ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
• Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
• Collaborating with Cross functional teams to resolve issues, complete investigations and maintain compliance.
• Assessing and approving Failure investigations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP's), GxP documents and Change control documents.
• Leading and supporting root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver.
• Evaluating procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
• Monitoring and trending metrics associated with site quality systems.
• Actively participating in continuous improvement ideas, initiation, and implementation.

The environment and physical rhythms of this role:

• Proven experience in conducting on-site investigations and analysis.
• Able to prioritise, re-prioritise as needed and adapt to change.
• Comfortable working in a fast-paced setting.
• Relationship builder with customers and internal key stakeholders.
• Comfortable in ambiguous environment and ability to translate ambiguity into actionable steps.

Let's find out if we're a fit:

• Specialist - BS/BA in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience.
• Sr Specialist - BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience.

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) €54,200.00 - €88,400.00