BioSpace Limerick, County Limerick, Ireland
Responsibilities
Developing an effective compliance framework for the Supply Chain department through the development and implementation of appropriate compliance related policies and procedures.
Acting as a liaison with onsite quality and regulatory groups to define and address all issues of non‑compliance.
Facilitating all reviews and revisions of all Supply Chain department related SOPs, plans and policies for each group within the department.
Providing support, information and assistance to individual groups and supervisors with the initiation, review, submission and follow‑up of documents such as CCs, NOEs, DNFs, impact statements and corrective action plans.
Driving a proactive compliance environment through completion of self‑audits, knowledge transfer and education of compliance related items.
Leading and participating directly in the investigation process and reviewing investigation reports.
Ensuring Corrective & Preventative Actions are appropriate, implemented as planned and have the intended efficiency.
Leading and managing Change Controls for Supply Chain.
Providing coaching to direct reports, including employee development plans, and fostering a healthy work environment where employees feel valued and respected.
Role Requirements
Previous experience in compliance and project management within a cGMP environment.
The ability to manage multiple, complex projects and changing priorities.
Effective decision‑making capabilities and ability to work in a team environment.
The ability to empower and direct a team, supervise and mentor staff.
Strong analytical skills and the ability to communicate details clearly and effectively.
Excellent attention to detail, time management and interpersonal skills.
To be considered for this opportunity you should have a BS/BA/BEng in Business, Supply Chain Management or Science background and 7 years of relevant experience in a cGMP environment or an equivalent combination of education and experience.
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.
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.S.-based 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.
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