Assoc Supply Compliance Analyst

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About the role

Summary:  Initiates, leads and executes compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within Supply Chain Management.   Essential Duties and Responsibilities : • Develops an effective compliance framework for all Supply Chain departments through the development and implementation of appropriate compliance related policies and procedures. • Acts as a liaison between the Supply Chain departments and onsite quality and regulatory groups to define and address all issues of non-compliance. • Facilitates all reviews and revisions of all Supply Chain department related SOPs, plans and policies for each group within the department. • Provides 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. • Drives a proactive compliance environment in all the Supply Chain teams through completion of self-audits, knowledge transfer and education of compliance related items. • Completes all required documentation in a manner which ensures compliance with all associated procedures. • Works with Subject Matter Experts to understand the scope of investigations as well as the business need. • Completes all associated documentation, forms and pre-work associated with change controls/investigations. • Works with other functional groups to assess impact as well as obtaining necessary review and approval of investigations. • Ensures 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. • Leads and/or participates directly in the investigation process. • Writes and/or reviews investigation reports. • Ensures Corrective & Preventative Actions are appropriate, implemented as planned and have the intended effectiveness. • Identifies recurring events and ensures appropriate actions are taken, such as notifying management. • Keeps team members informed of the status of assigned work. • Leads and manages Change Controls for Supply Chain. • Works with the team to develop robust training programs. • Identifies opportunities for improvement within Supply Chain systems and communicates those opportunities to management. • Embraces and promotes the IOPS culture and the Regeneron Way. • Assists in deploying IOPS Regeneron’s values and culture throughout the Supply Chain team. Education and Experience: • Associate Analyst: Requires bachelor’s degree in Business, Supply Chain Management or Science background or equivalent combination of education and experience. • Analyst: Requires bachelor’s degree in Business, Supply Chain Management or Science background and 2 years of experience in a cGMP environment or equivalent combination of education and experience. • Senior Analyst: Requires bachelor’s degree in Business, Supply Chain Management or Science background and 5 years of experience in investigations/change controls in a cGMP environment or equivalent combination of education and experience. • Experience in a cGMP environment preferred. • Experience in pharmaceutical / biotech industry is a plus.   Knowledge, Skills and Abilities: • Excellent written and verbal communication skills. • Strong analytical and organizational skills. • Able to prioritize, re-prioritize as needed and adapt to change. • Comfortable working in a fast-paced setting. • Relationship builder with customers and internal key stakeholders. • Comfortable in ambiguous environment and ability to translate ambiguity into actionable steps. • Courage to ask questions in a cross-functional setting. • Proficiency in MS Office, Excel

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