Job Description
Job Title: Supply Compliance Senior/Analyst
Location: [Unknown Location]
This role is responsible for initiating, leading, and executing compliance-related activities across all areas within Supply Chain Management.
Key Responsibilities:
* Develop an effective compliance framework for all Supply Chain departments through the development and implementation of appropriate compliance-related policies and procedures.
* Act as a liaison between Supply Chain departments and onsite quality and regulatory groups to define and address all issues of non-compliance.
* Facilitate reviews and revisions of all Supply Chain department-related SOPs, plans, and policies.
* Support 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.
* Drive a proactive compliance environment in all Supply Chain teams through completion of self-audits, knowledge transfer, and education of compliance-related items.
* Complete required documentation to ensure compliance with associated procedures.
* Work with Supply Chain personnel to understand the scope of investigations and business need.
* Complete associated documentation, forms, and pre-work related to change controls/investigations.
* Work with other functional groups to assess impact and obtain necessary review and approval of investigations.
* Ensure timely completion of investigation and resolution of non-conformities in compliance with Regeneron procedures and regulatory requirements.
* Lead and/or participate directly in the investigation process.
* Write and/or review investigation reports.
* Ensure Corrective & Preventative Actions are implemented as planned and have intended effectiveness.
* Identify recurring events and take appropriate actions.
* Keepteam members informed of assigned work status.
* Manage Change Controls for Supply Chain.
* Develop robust training programs with the team.
* Communicate opportunities for improvement within Supply Chain systems to management.
* Deploy Regeneron's values and culture throughout the Supply Chain team.
Requirements:
* 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.
* Proficient skills in MS Office, Excel, Oracle, PowerPoint, and Access Database.
* Ability to focus on continuous improvement.
Education and Experience:
* BS/BA in Business, Supply Chain Management, or Science background.
* 10 years of experience in investigations/change controls in a cGMP environment or equivalent combination of education and experience.
Salary Range:
$ [Estimated Salary] - $ [Estimated Salary]