Staff IT Compliance Analyst

Regeneron Ireland; Limerick; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading biotechnology company in County Limerick is seeking a Staff IT Compliance Analyst to ensure compliance with regulatory requirements and manage audits. You will provide expert guidance, prepare the team for audits, and maintain compliance metrics. Candidates should have over 5 years of relevant experience and a solid understanding of IT compliance within the pharmaceutical industry. Join us for an inclusive culture with comprehensive benefits.

Benefits

Health and wellness programs

401(k) company match

Annual bonuses

Qualifications

• 5+ years of experience in IT Compliance/Quality Assurance within the biotechnology or pharmaceutical industry.
• Experience in systems validation/qualification.
• Strong understanding of FDA and EU regulations.

Responsibilities

• Ensure compliance with regulatory requirements and internal procedures.
• Prepare for internal and external audits.
• Collaborate with global sites to meet compliance expectations.

Skills

GXP regulations knowledge

IT Compliance experience

Quality Assurance experience

Education

BS/BA in Information Technology or related field

Job description

The Staff IT Compliance Analyst is responsible for ensuring that the manufacturing IT group is operating in compliance with regulatory requirements and Regeneron internal procedures and manage the internal and external audits. As a Staff IT Compliance Analyst, a typical day might include the following:

• Provide expert analysis and guidance to manufacturing IT team in regulatory/quality related area and manage an internal program to prepare for internal and external audits readiness.
• Evaluates, develops and modifies manufacturing IT Policies and Standard Operating Procedures plus company practicies to meet regulatory and corporate requirements and obligations.
• Represents and assists manufacturing IT SMEs during internal and external audits and lead the responses to audit findings.
• Establish, maintain and improve metrics to track IT compliance & Inspection Readiness and communicate those findings
• Work collaboratively with our global sites to ensure systems deployed are managed and supported to meet the compliance expectations/requirements of the business while champoining Data Integrity.
• Monitor industry wide trends in audit observations, assess gaps if any and take appropriate timely actions.
• Performing other duties assigned by IT management, demonstrating flexibility and a broad understanding of IT functions. (e.g. IT Deviations, IT Change Controls, Creating/Updating IT Documents)

This role may be for you if you have:

• A deep understanding of GXP regulations (FDA 21 CFR Part 11, EU Annex 11) and IT systems Validation/qualification.
• 5+ years of experience in IT Compliance/Quality Assurance within biotechnology or pharmaceutical industry.

In order to be considered for this position, you must hold a BS/BA in Information Technology or related field required along with

• Principal IT Compliance Analyst: 8 years of relevant experience.
• Staff IT Compliance Analyst: 10 years of relevant experience.
• May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.
• Quality Assurance (QA) experience strongly desired.Experience in the pharmaceutical or biotechnology industry preferred.

Does this sound like you?

Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.