Assoc Supply Compliance Analyst

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a compliance-focused professional to lead and execute activities across the Supply Chain Management function. The role centers on investigations, change controls, CAPA and cross-functional collaboration to uphold regulatory standards.

The ideal candidate will develop robust compliance programs, partner with quality and regulatory teams, and drive timely documentation and remediation actions in a fast-paced biotech environment.

Qualifikationen

• Bachelor's degree in Business, Supply Chain Management or Science.
• 2+ years in a cGMP environment (analyst level).
• 5+ years in investigations/change controls in a cGMP environment (senior analyst).
• Experience in pharmaceutical/biotech industry is a plus.

Aufgaben

• Develops an effective compliance framework for all Supply Chain departments.
• Acts as a liaison between Supply Chain and QA/regulatory groups to address non-compliance.
• Facilitates reviews and revisions of SOPs, plans and policies for the department.
• Supports submission and follow-up of documents such as CCs, NOEs, DNFs, and CAPAs.

Kenntnisse

Communication

Analytical

MS Office

Excel

PowerPoint

Lean/CI

APICS certs a plus

Regulatory knowledge

Investigations

Ausbildung

Bachelor's degree in Business or Supply Chain or Science

2+ years in cGMP environment

Tools

MS Word

Jobbeschreibung

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, and PowerPoint Database.
• Continuous improvement focus.
• Lean/Continuous Improvement knowledge a plus.
• APICS or other related purchasing certifications a plus.

We are committed to building a workplace with an inclusive culture.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose un