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 ensuring appropriate actions are taken, such as notifying management.
* Keeping team members informed of the status of assigned work.
* Leading and managing Change Controls for Supply Chain.
* Working with the team to develop robust training programs.
* Identifying opportunities for improvement within Supply Chain systems and communicating 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.
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