Document Control & Training Manager, Contractor

Job Locations US-NJ-Florham Park
ID
2020-1255
Category
Quality
Type
Contract

Overview

Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com).  Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.

 

As a Document Control & Training Manager, Contractor, you will provide day-to-day quality support, management, leadership and guidance across the organization with focus on documentation and training programs. As Business Process Owner, you will institutionalize and expand processes and automation, which includes L&D, document control and records management, to deliver required information to the relevant users when they need it in an effective, efficient and compliant way.

 

Responsibilities

  1. Business Process Owner for Document Control system and Training quality systems (including automation within Veeva)
  2. Establishes and maintains L&D/training program, owned within Quality 
  3. Established strategy for rolling out training to who needs it, when they need it, with the needed information: training tiered and phased approach of awareness, knowledge, competency, update 
  4. Identify and collaborate with stakeholders and people-leaders for appropriate learning mechanisms for content to be delivered by SME (e.g., classroom, R&U, online, AI, demonstration); identify training needs and requirements, define and document roll-based training matrices 
  5. Manages Document Control and Training quality systems operations and compliance activities for GxP teams
  6. Identifies and implements quality system improvements for document control and training processes and procedures based on performance metrics and stakeholder feedback.
  7. Monitors and reports relevant quality system performance metrics
  8. Assesses documents for accuracy, simplicity, and practicality and influences changes as appropriate
  9. Ensures alignment between procedural changes, training strategy and training materials including accordance with approved change implementation plans
  10. Ensures site document owners and authors are properly trained and are notified of significant policy or procedural changes
  11. Provides training to new users and ongoing support to internal stakeholders as needed
  12. Assists in the development and revision of training materials as necessary
  13. Partners with functional areas to ensure delivery of training plans, qualified trainers program, new hire orientation, and alignment to regulatory standards
  14. Support and promote the alignment and harmonization of quality management processes and practices across sites (e.g., corporate quality management system)
  15. Support audits (internal, external, third party) as needed including preparation, back-room activities, scribing as needed
  16. Support quality management review meetings preparation, scheduling, scribing, follow-up
  17. Performs routine system administrative support that includes enrolling, activating, managing and deactivating users, and the users' role criteria and assignments 

Qualifications

  • Bachelor’s degree in a related field from an accredited college or university preferably in Science, Information Technology, Engineering or equivalent
  • Minimum of 5+ years of experience in quality assurence within a GXP regulated field or function. GMP expereince is required.
  • 3 years of experience leading learning and training programs and initiatives, designing corporate training programs within a regulated life science field 
  • 3+ years of experience / expertise with administration of a Learning Management System 
  • Knowledge and understanding of adult learning strongly preferred 
  • Knowledge/experience with electronic quality system and EDMS required (Prior Veeva experience strongly preferred)
  • Business engagement skills, with ability to collaborate with both technical and non-technical roles
  • Verbal and written communication skills including persuading others and developing cross functional relationships both at site and across sites
  • Managing multiple projects, duties and tasks with minimal supervision
  • Analytical problem-solving skills applied to issue identification and resolution
  • Ability to respond to changing priorities

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