Job Description
Within this role you will be responsible for initiating, leading and executing compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within Supply Chain Management. As a Supply Compliance Senior / Analyst, a typical day might include, but is not limited to, the following: Developing an effective compliance framework for all Supply Chain departments through the development and implementation of appropriate compliance related policies and procedures Acting as a liaison between the Supply Chain departments and 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 in all the Supply Chain teams through completion of self-audits, knowledge transfer and education of compliance related items Completing all required documentation in a manner which ensures compliance with all associated procedures Working with Supply Chain personnel to understand the scope of investigations as well as the business need Completing all associated documentation, forms and pre-work associated with change controls/investigations Working with other functional groups to assess impact as well as obtaining necessary review and approval of investigations Ensuring that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements Leading and/or participating directly in the investigation process Writing and/or reviewing investigation reports Ensuring Corrective & Preventative Actions are appropriate, implemented as planned and have the intended effectiveness Identifying recurring events and ensures appropriate actions are taken, such as notifying management Keeping team members informed of the status of assigned work Leading and manages Change Controls for Supply Chain Working with the team to develop robust training programs Identifying opportunities for improvement within Supply Chain systems and communicates those opportunities to management Assisting in deploying Regeneron's values and culture throughout the Supply Chain team This role might be for you if: You have excellent written and verbal communication skills You demonstrate strong analytical and organizational skills You have the ability to prioritize, re-prioritize as needed and adapt to change. You are comfortable working in a fast-paced setting You have proficient skills in MS Office, Excel, Oracle, PowerPoint and Access Database You have the ability to focus on continuous improvement To be considered for this opportunity you should have a BS/BA in Business, Supply Chain Management or Science background and 10 years of experience in investigations/change controls in a cGMP environment or equivalent combination of education and experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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.