Sr Manager Supplier Quality and Compliance

We are currently looking to fill a Sr Manager Supplier Quality and Compliance. In this role you will be responsible for overseeing a team that supports and maintains all cGMP compliance aspects of procurement operations. Some of the major activities include but are not limited to the following: 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 the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. Additional responsibilities include other compliance tasks and functions as assigned.

In this role, a typical day may include the following:

Ensures that the team operates as a global cohesive unit taking advantage of the efficiencies and ensuring compliance for all IOPS sites.
Tracks progress on all Strategic Sourcing & Procurement quality system deliverables, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates.
Interfaces regularly with Quality Assurance and other functional areas to remove obstacles, resolve conflicts, and to help facilitate critical decisions pertaining to quality system deliverables.
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 and maintains all Procurement cGMP procedures, documentation and training related to SOPs and Work Instructions.
Continually reassess’ Strategic Sourcing & Procurement systems and processes for adherence to cGMPs and industry best practices and implements changes/improvements as needed.
Represents the Strategic Sourcing & Procurement department on various topics during regulatory inspections, and coordinates responses to inspection observations as applicable.
Supports the start-up/integration of Strategic Sourcing & Procurement compliance functions at other IOPS sites, including travel as needed.

This role may be a fit for you if you:

Can oversee and direct the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers.
Drive 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.
Can lead 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.
Have the ability to work closely with Legal, QA and suppliers to help facilitate the execution and management of Master Services Agreements, Quality Agreements, etc. as required.
Can action on the procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders.

To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience:

Sr Manager level: 8+ years of relevant experience, with at least 5 years of relevant experience in a cGMP environment or equivalent combination of education and experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$126,300.00 - $206,100.00

Details

Location

Rensselaer, NY 12144, USA

Salary

$126,300 – $206,100/year

Experience

Min. 8 yearsSr Manager level: 8+ years of relevant experience, with at least 5 years of relevant experience in a cGMP environment or equivalent combination of education and experience.

In this role, a typical day may include the following:

Ensures that the team operates as a global cohesive unit taking advantage of the efficiencies and ensuring compliance for all IOPS sites.
Tracks progress on all Strategic Sourcing & Procurement quality system deliverables, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates.
Interfaces regularly with Quality Assurance and other functional areas to remove obstacles, resolve conflicts, and to help facilitate critical decisions pertaining to quality system deliverables.
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 and maintains all Procurement cGMP procedures, documentation and training related to SOPs and Work Instructions.
Continually reassess’ Strategic Sourcing & Procurement systems and processes for adherence to cGMPs and industry best practices and implements changes/improvements as needed.
Represents the Strategic Sourcing & Procurement department on various topics during regulatory inspections, and coordinates responses to inspection observations as applicable.
Supports the start-up/integration of Strategic Sourcing & Procurement compliance functions at other IOPS sites, including travel as needed.

This role may be a fit for you if you:

Can oversee and direct the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers.
Drive 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.
Can lead 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.
Have the ability to work closely with Legal, QA and suppliers to help facilitate the execution and management of Master Services Agreements, Quality Agreements, etc. as required.
Can action on the procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders.

To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience:

Sr Manager level: 8+ years of relevant experience, with at least 5 years of relevant experience in a cGMP environment or equivalent combination of education and experience.

Salary Range (annually)

$126,300.00 - $206,100.00