Assoc Supply Compliance Analyst

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 92,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Compliance professional within Supply Chain Management to initiate, lead and execute investigations, CAPAs and change controls across the department.

You will collaborate with onsite quality and regulatory groups to define and address non‑compliance and ensure documentation aligns with Regeneron procedures. Responsibilities include developing policies, driving self-audits, and promoting continuous improvement through training and cross‑functional

Qualifications

• Bachelor’s degree in Business, Supply Chain Management or Science, or equivalent.
• 2 years of experience in a cGMP environment (Analyst level).
• 5 years of experience in investigations/change controls in a cGMP environment (Senior Analyst).

Responsibilities

• Develops an effective compliance framework for all Supply Chain departments through policies and procedures.
• Acts as a liaison between Supply Chain and onsite quality/regulatory groups.
• Leads investigations and change controls within Supply Chain and reviews related reports.
• Ensures timely documentation and corrective actions across the department.

Skills

Excellent communication

Strong analytical skills

MS Office

Education

Bachelor’s degree in Business, Supply Chain Management or Science

Tools

MS Office

Excel

PowerPoint

Job description

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.
• Drivers 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.

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.

Equal Opportunity / Diversity Statement

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 undue hardship.

Background Checks and Eligibility

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$62,355.00 - $92,400.00

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Benefits and Total Rewards

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For other locations, additional information will be provided during the recruitment process.

Company Description

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.