-
Job Description
Job Description: Initiate, lead, and execute compliance activities, such as investigations, change controls, CAPA, and reviews of SOPs, plans, and policies across Supply Chain Management.
- Develop compliance framework for Supply Chain departments through policy and procedure development.
- Act as liaison between Supply Chain and onsite quality and regulatory groups to address non-compliance issues.
- Facilitate reviews and revisions of SOPs, plans, and policies for Supply Chain departments.
- Provide support and assistance to groups and supervisors with document initiation, review, and submission.
- Drive proactive compliance environment through self-audits, knowledge transfer, and education of compliance-related items.
- Complete required documentation in compliance with procedures.
Responsibilities:
- Work with Supply Chain personnel to understand investigation scope and business need.
- Complete documentation, forms, and pre-work associated with change controls/investigations.
- Assess impact and obtain necessary review and approval of investigations.
- Ensure timely and compliant resolution of non-conformities.
- Lead and/or participate in investigation process.
- Write and/or review investigation reports.
- Ensure Corrective & Preventative Actions are effective.
- Identify recurring events and take appropriate actions.
- Keep team members informed of work status.
- Lead and manage Change Controls for Supply Chain.
- Develop robust training programs with team.
- Identify opportunities for improvement and communicate to management.
- Deploy Regeneron's values and culture throughout Supply Chain team.
Requirements:
- 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.
- Excellent written and verbal communication skills.
- Strong analytical and organizational skills.
- Ability to prioritize, re-prioritize, and adapt to change.
- Proficient skills in MS Office, Excel, Oracle, PowerPoint, and Access Database.
Additional Information:
Regeneron is an equal opportunity employer. We provide comprehensive benefits, inclusive culture, and opportunities for continuous improvement. We are committed to diversity, equity, and inclusion. Please note that certain background checks will form part of the recruitment process.
© Regeneron.