Assoc Supply Compliance Analyst

Regeneron Pharmaceuticals

3d•CA$62,355 - CA$92,400•Onsite

About The Position

Initiates, leads and executes compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within Supply Chain Management.

Requirements

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.
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.

Nice To Haves

Experience in a cGMP environment preferred.
Experience in pharmaceutical / biotech industry is a plus.
Continuous improvement focus.
Lean/Continuous Improvement knowledge a plus.
APICS or other related purchasing certifications a plus.

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.