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:
1. Developing an effective compliance framework for all Supply Chain departments through the development and implementation of appropriate compliance related policies and procedures.
2. Acting as a liaison between the Supply Chain departments and onsite quality and regulatory groups to define and address all issues of non-compliance.
3. Facilitating all reviews and revisions of all Supply Chain department related SOPs, plans and policies for each group within the department.
4. 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.
5. Driving a proactive compliance environment in all the Supply Chain teams through completion of self-audits, knowledge transfer and education of compliance related items.
6. Completing all required documentation in a manner which ensures compliance with all associated procedures.
7. Working with Supply Chain personnel to understand the scope of investigations as well as the business need.
8. Completing all associated documentation, forms and pre-work associated with change controls/investigations.
9. Working with other functional groups to assess impact as well as obtaining necessary review and approval of investigations.
10. 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.
11. Leading and/or participating directly in the investigation process.
12. Writing and/or reviewing investigation reports.
13. Ensuring Corrective & Preventative Actions are appropriate, implemented as planned and have the intended effectiveness.
14. Identifying recurring events and ensures appropriate actions are taken, such as notifying management.
15. Keeping team members informed of the status of assigned work.
16. Leading and managing Change Controls for Supply Chain.
17. Working with the team to develop robust training programs.
18. Identifying opportunities for improvement within Supply Chain systems and communicates those opportunities to management.
19. Assisting in deploying Regeneron’s values and culture throughout the Supply Chain team.
This role might be for you if:
1. You have excellent written and verbal communication skills.
2. You demonstrate strong analytical and organizational skills.
3. You have the ability to prioritize, re-prioritize as needed and adapt to change.
4. You are comfortable working in a fast-paced setting.
5. You have proficient skills in MS Office, Excel, Oracle, PowerPoint and Access Database.
6. 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.
#J-18808-Ljbffr