Compliance Manager - Sourcing
Company: Regeneron Pharmaceuticals, Inc.
Posted on: June 25, 2022
Job Title: - -Manager Compliance - SourcingDepartment: 0604-
Strategic Sourcing & ProcurementLocation: -Rensselaer, NYSUMMARY:
The Manager Compliance - Sourcing is responsible for overseeing 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. - - -SCOPE: - GlobalJOB
- Leads and develops the Global IOPS Strategic Sourcing &
Procurement compliance employees.
- 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.
- 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 in order to remove obstacles, resolve conflicts,
and to help facilitate critical decisions pertaining to quality
- 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.
- 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.
- 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.
- Actions the procurement responses to compliance related
requests for data from Regulatory, Quality Assurance, Audit staff
and other stakeholders.Education
- Bachelor's degree (BA/BS) with 7+ years of relevant experience,
with at least 5 years of relevant experience in a cGMP
- Master's degree with 5+ years of relevant experience, with at
least 4 years of relevant experience in a cGMP
- Requires prior experience managing or leading teams.
- Familiarity and experience working in an ERP system is
- Excellent collaboration skills and the ability to work cross
functionally across categories and internal stakeholders.
- Strong attention to detail is required.
- Microsoft Office required including strong Power Point and
- Acts with integrity in every aspect of the work and in line
with Regeneron values.
- Makes decisions that put scientific and professional integrity
and patient safety first.
- Makes good decisions based upon a mixture of analysis,
knowledge, experience and judgment.
- Translates business objectives into actionable priorities.
- In depth understanding of cGMP systems and processes with
particular emphasis on compliance required.
Keywords: Regeneron Pharmaceuticals, Inc., Troy , Compliance Manager - Sourcing, Executive , Troy, New York
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