Senior QA Specialist

BioSpace; Ireland (WV); On-site; USD 61,000 - 99,000; Full time

Job summary

Regeneron in Raheen, Limerick, Ireland, is seeking a Senior QA Specialist to join our Quality Assurance team and lead QA activities for technology transfer and digital systems within GMP environments.

You will collaborate with Manufacturing, Engineering, IT, Validation, and Supply Chain to ensure risk management, regulatory compliance, and effective implementation of MES, electronic batch records, and digital initiatives across projects.

Qualifications

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

Responsibilities

• Lead and support QA activities for technology transfer projects, ensuring knowledge transfer and risk management.
• Provide QA leadership for introduction of new manufacturing technologies, equipment, computerized systems, and digital solutions.
• Partner with Manufacturing, Engineering, IT, Validation, and Supply Chain to support cross-functional initiatives.
• Facilitate governance, risk assessments, and quality decisions for technology implementations and digitalization programs.
• Drive data-driven quality processes, visibility, and compliance across MES, electronic batch records, and data integrations.
• Support development of quality strategies, procedures, training materials, and governance frameworks for new tech initiatives.
• Monitor project progress, quality risks, and KPIs for technology transfer and digital transformation programs.

Education

BS/BA in scientific discipline

MS in related 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 Senior QA Specialist to join our Quality Assurance team.

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

Where

Location: Raheen, Limerick

What Youll Do

• Leading and supporting Quality Assurance activities associated with technology transfer projects, ensuring effective knowledge transfer, risk management, and implementation of quality requirements.
• Providing Quality Assurance project leadership and oversight for the introduction of new manufacturing technologies, equipment, computerized systems, and digital solutions.
• Partnering with Manufacturing, Engineering, IT, Validation, Supply Chain, and other cross-functional stakeholders to support projects and initiatives across IOPS.
• Facilitating project governance, risk assessments, and quality decision-making for technology implementation and digitalization programs.
• Driving the adoption of data-driven and digital approaches that enhance quality processes, visibility, review efficiency, compliance, and operational performance.
• Supporting the implementation of systems and technologies including Manufacturing Execution Systems (MES), electronic batch records, automation solutions, data integration platforms, and advanced manufacturing technologies.
• Finding opportunities for process simplification, automation, and digital innovation while ensuring compliance with applicable regulatory requirements and company procedures.
• Supporting the development of quality strategies, procedures, training materials, and governance frameworks associated with new technologies and digital initiatives.
• Monitoring project progress, quality risks, and key performance indicators associated with technology transfer, digitalization, and business transformation programs.

The Environment And Physical Rhythms Of This Role

• Excellent project, time, and priority management skills, with the ability to independently manage multiple complex assignments simultaneously, adapt to changing priorities, and drive tasks through to successful completion with minimal supervision.
• Solid understanding of technology transfer principles and lifecycle management within a GMP-regulated environment.
• Understanding of computerized system implementation, validation principles, data integrity requirements, and applicable regulations including 21 CFR Part 11, Annex 11, and GxP expectations.
• Familiarity with digital manufacturing systems and technologies, including MES, electronic batch records, automation platforms, data historians, analytics tools, and system integrations.
• Knowledge of quality risk management methodologies and their application to new technology implementation and process changes.
• Ability to work optimally across technical and business functions to deliver complex transformation initiatives.
• Experience supporting continuous improvement, digital transformation, operational excellence, or innovation programs within a regulated industry.

Lets Find Out If Were a Fit

• 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.
• Specialist: 2 years experience

Thrive today. Grow tomorrow.

#IRELIM #JOBSIEST #REGNQA

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.

We also 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, and 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 onsite.

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.

Salary Range (annually) 54,200.00 - 88,400.00