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