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Manager Compliance - Sourcing

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
May 8, 2023

View more

Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

We are looking for a Manager Compliance – Sourcing to supervise a team of Strategic Sourcing & Procurement Compliance Specialists that support and maintain all cGMP compliance aspects of procurement operations. The major activities include but are not limited to the following: Leading the management and facilitation of the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP writing and revision, change controls, and providing secondary support to the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. Other compliance tasks/functions as assigned.

A typical day might include:
  • Ensures that the team of compliance employees operate as a global cohesive unit taking advantage of the efficiencies and ensuring compliance for all IOPS sites.
  • Monitors, reports, and responds to Key Performance Indicators (KPIs) for the compliance functions, e.g. right-first-time (RFT) for deviation investigations.
  • Performs deviation investigations and coordinates CAPA implementation as needed for high-risk events.
  • Proactively manages process improvement initiatives related to all Procurement cGMP procedures, documentation and training related to SOPs and Work Instructions.
  • Oversees/directs the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers.
  • Supplier Audit Compliance – Drives successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures and gathering of evidence of closure for raw material and component suppliers.
  • Leads the coordination with Cross Functional Compliance resources to support procurement and Quality Auditing needs for acceptable closure of Internal Regeneron and Supplier audit findings and to secure evidence that substantiates commitments. Tracks and reports CAPA in support of audit closure.

This role might be for you if you have:

A Bachelor’s degree (BA/BS) with 7+ years of relevant experience, with at least 5 years of relevant experience in a cGMP environment or a Master’s degree with 5+ years of relevant experience, with at least 4 years of relevant experience in a cGMP environment. An ideal candidate will have in depth understanding of cGMP systems and processes with particular emphasis on compliance required.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$101,800.00 - $166,000.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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