Associate Director GD Training Quality
Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: January 20, 2023
Job Description:
This role is pivotal to the effective management of the training
system, using LMS data and feedback to strengthen training delivery
& compliance, as part of the overall Quality Management System.
Reporting to the Director of the LCoE Quality & Compliance, this
individual will be accountable for driving the strategy and
implementation of training systems & processes in accordance with
ICH/GCP requirements. Supporting the business requirements of large
user groups in Research & pre-clinical Development, Global Clinical
Development and Regulatory Affairs & Global Patient Safety, the
LCoE Quality & Compliance team also manage the GxP Learning
Management System requirements for all other enterprise functions
outside of manufacturing. In this role, a typical day might include
the following:
- Applies advanced in-depth and broad knowledge of business and
Learning Management Systems to inform strategic planning for the
LCoE organization.
- Anticipates business needs, secures required resources, and
leads initiatives to implement change in the LCoE as well as across
the organization.
- Finds opportunities to initiate operational changes and policy
modifications within LCoE and supported partners to improve
training quality and compliance. Ensures portfolio level project
management effectiveness through effective system utilization,
accurate data aggregation, and valuable reporting and
dashboards
- As LMS System Owner, reviews proposed changes & upgrades to the
LMS, and approves access requests for specialist non-learner
roles.
- Provides technical guidance to collaborators regarding training
assignments & workflows to ensure sustainable & robust solutions
are applied.
- Participates in regulatory & internal audits & inspections,
answers auditor questions and when necessary, works to resolve
CAPAs to address compliance requirements.This role might be for you
if:
- You have a consistent track record as an advisor providing
recommendations to senior executives on matters concerning training
quality and compliance.
- You're a recognized subject matter expert throughout the
organization as a vital resource in activities related to LMS,
training quality & training compliance.
- As a leader, you have partnered at all levels and provided
advice to senior management on complex/strategic issues surrounding
training and compliance.
- You possess the ability to evaluate the effectiveness of
training using business analytics tools to report on trends &
issues, facilitating data driven decisions.To be considered for
this opportunity you must possess Bachelors degree with ideally 10+
years Clinical, Pharmaceutical or Medical Device experience with
understanding of GxP guidelines. Experience working as a LMS
administrator within a complex, matrix organization. Proficient
working with relevant software: SharePoint 2016 & SharePoint
Modern.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) $148,100.00 - $241,700.00
Keywords: Regeneron Pharmaceuticals, Inc., Newark , Associate Director GD Training Quality, Accounting, Auditing , Basking Ridge, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...