Temp Quality Compliance Specialist

Regeneron Ireland; Limerick; Presencial; EUR 52 000 - 70 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonuses

Equity awards

Pension benefits

401k match

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Resumo da oferta

Regeneron Ireland seeks a Temporary Quality Compliance Specialist to join the Quality Assurance Raw Materials team at the Raheen site in Limerick. You will ensure compliance across all quality aspects, oversee quality systems, and participate in audits and improvement initiatives.

The role requires a BSc/BEng in a scientific field and 3+ years of relevant pharmaceutical experience. Competitive benefits and a dynamic, fast-paced environment are offered.

Qualificações

• Requires a quality mindset with meticulous attention to detail and adherence to quality systems.
• Experience working in pharmaceutical or related industry is preferred.
• Demonstrates strong communication and collaboration across functions.

Responsabilidades

• Ensure compliance with all aspects of Quality for the Raheen site and oversee site quality systems.
• Review and approve failure investigations, change controls, CAPA and deviations.
• Maintain electronic systems used for Change Control and Deviation Management.
• Review procedures and policies to ensure compliance with regulatory requirements.
• Monitor and trend metrics related to site quality systems.
• Participate in regulatory and customer audits and quality risk assessments.
• Collaborate with departments to resolve issues and maintain compliance.

Conhecimentos

Quality mindset

Attention to detail

Interpersonal skills

Formação académica

BSc/BEng in scientific discipline or related field

Descrição da oferta de emprego

Company

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.

Job 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

Work Environment and Skills

• Have a quality mindset and excellent attention to detail
• Demonstrate strong interpersonal skills
• Be comfortable working in a fast-paced setting

Qualifications

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

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

Equal Opportunity Employer

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.

Salary and Compensation Disclosure

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.

Background Checks

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.

Additional Information

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.