Temp Quality Compliance Specialist

Regeneron Pharmaceuticals, Inc; Limerick; On-site; EUR 55,000 - 75,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick is seeking a Temporary Quality Compliance Specialist to join the Quality Assurance Raw Materials team.

You will help ensure quality systems and regulatory compliance at the Raheen site. Responsibilities include reviewing investigations, change controls, CAPA, deviations and SOPs; maintaining electronic QA systems; monitoring quality metrics; and supporting internal and regulatory audits.

Qualifications

• BSc or BEng in a scientific field with 3+ years pharma experience.
• Experience in quality systems, deviations, CAPA and change control.

Responsibilities

• Ensure compliance with all quality aspects for the Raheen site and oversee site quality systems.
• Review and approve failure investigations, CAPAs, change controls, and SOPs.
• Maintain electronic systems for Change Control and Deviation Management.
• Review procedures, policies and other instructional documents for regulatory compliance.
• Monitor quality metrics and participate in continuous improvement initiatives.
• Participate in regulatory and customer audits and quality risk assessments.
• Collaborate with departments to resolve issues and maintain compliance.

Skills

Quality mindset

Attention to detail

Interpersonal skills

Regulatory compliance

Education

BSc / BEng in scientific field

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Temporary Quality Compliance Specialist to join our Quality Assurance Raw Materials 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 and administration and oversight of site quality systems including deviations, CAPA Change Control, Audits, Customer Complaints and Quality Risk Management
• Reviewing and approving failure investigations, change control documents, corrective/preventative action documents and standard operating procedures
• Maintaining electronic systems used for Change Control and Deviation Management
• Reviewing 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 initiatives
• Participating in regulatory and customer audits and quality risk assessments
• Collaborating with functional departments to resolve issues and maintain compliance

The environment and physical rhythms of this role:

• You have a quality mindset and excellent attention to detail
• You demonstrate strong interpersonal skills
• You are comfortable working in a fast-paced setting

Let’s find out if we’re a fit:

• Requires BSc/BEng in scientific discipline or related field with 3+ years of relevant work experience in pharmaceutical or related industry.

Thrive today. Grow tomorrow.

We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.