Snr QA Compliance Specialist

Regeneron Ireland; Limerick; Presencial; EUR 46.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

annual bonuses or other incentiveplans

equity awards

pension or retirement benefits

401(k) company match

health and wellness programs

fitness centers

insurance benefits (e.g. medical, dent

insurance benefits (e.g. medical, dent

paid time off

family support benefits

Descripción de la vacante

Regeneron Ireland seeks a QA Compliance Specialist to join the QA Compliance & Quality Systems team in Raheen, Limerick. You will support Change Control records administration, provide quality oversight across the change lifecycle, and review key quality documentation to ensure regulatory compliance.

You'll collaborate with Manufacturing, QA, Engineering, Validation, and Supply Chain to assess impacts and ensure timely execution of changes, CAPAs, and risk assessments, contributing to a robust

Formación

• 3–5+ years of relevant experience in the pharmaceutical/biotechnology industry.
• Experience with Quality Systems, Change Controls, Deviations, CAPA's, and risk management.
• Working knowledge of cGMP requirements and regulatory expectations.

Responsabilidades

• Supporting administration, review, and coordination of Change Control records to ensure regulatory compliance.
• Providing quality oversight of Change Control activities across the lifecycle.
• Reviewing and approving Quality System documentation (Change Controls, Deviation investigations, CAPA's, SOPs, Work Instructions).
• Collaborating with Manufacturing, QA, Engineering, Validation, Supply Chain, MSAT and others to assess impacts and implement changes.
• Ensuring Change Controls are categorized, documented, and tracked within timelines.
• Supporting quality system governance, monitoring open records, escalating risks, and driving corrective actions.
• Assisting in training on Change Control and Quality System processes.
• Participating in continuous improvement initiatives to enhance Quality System effectiveness.

Conocimientos

Quality Systems

Change Controls

Deviations

CAPA

Audit Management

Risk Management

Regulatory knowledge

Educación

Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline

Descripción del empleo

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a QA Compliance 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

What you’ll do:

• Supporting the administration, review, and coordination of Change Control records to ensure compliance with company procedures and regulatory requirements.
• Providing quality oversight of Change Control activities throughout the change lifecycle, including initiation, impact assessment, implementation, effectiveness verification, and closure.
• Reviewing and approving Quality System documentation, including: Change Control records, Deviation investigations, CAPA's, Risk assessments, Standard Operating Procedures and Work Instructions and associated quality documentation.
• Collaborating with Manufacturing, Quality Control, Engineering, Validation, Supply Chain, MSAT, and other functional areas to ensure appropriate assessment and implementation of proposed changes.
• Ensuring Change Controls are appropriately categorised, documented, assessed for impact, and progressed in accordance with established timelines.
• Supporting quality system governance activities, including monitoring open records, escalating risks, and driving timely completion of actions.
• Assisting in the generation, monitoring, and trending of Quality System metrics to support management review and continuous improvement initiatives.
• Participating in investigations related to Change Controls and supporting identification and implementation of corrective and preventive actions where required.
• Supporting the development and delivery of training on Change Control and Quality System processes.
• Actively participating in continuous improvement initiatives to enhance Quality System effectiveness, compliance, and efficiency.

The environment and physical rhythms of this role:

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.

Biologics manufacturing experience desirable.

Let’s find out if we’re a fit:

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• Requires 3-5+ years of relevant experience in the pharmaceutical, biotechnology, or other regulated industry.
• Relevant experience may be considered in lieu of educational requirements.

Benefits

• 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

Salary Range (annually) €46,200.00 - €75,400.00

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

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.

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, and family support benefits.

For other locations, additional information will be provided during the recruitment process.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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.

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.