BioSpace Limerick, County Limerick, Ireland
Staff IT Compliance Analyst
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.
Typical Day
* 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 practices 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 championing 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).
Qualifications
* 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 along with experience:
* Principal IT Compliance Analyst: 8 years of relevant experience.
* Staff IT Compliance Analyst: 10 years of relevant experience.
* Level determined based on qualifications; may consider equivalent combination of education and experience.
* Quality Assurance (QA) experience strongly desired.
* Experience in the pharmaceutical or biotechnology industry preferred.
Benefits: 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter.
EEO Statement
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology
Industries
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