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QMS Training Manager

21 hours, 28 minutes ago
Anywhere
Full-time
Senior
Training Manager
Operations
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
View All Jobs 14

Description

  • Manage curricula, learner roles, and periodic reviews of training requirements with department heads and QMS administration.
  • Coordinate with study team leads to update study-specific training documents and manage study team learner role membership in the LMS.
  • Work with document owners and document control to create or revise training requirements tied to controlled documents and training materials.
  • Partner with hiring managers to launch training plans for new or changing learner roles.
  • Collaborate with hiring managers and HR to review and approve onboarding forms.
  • Coordinate training and QMS orientation for new hires and assign them to appropriate curricula and learner roles.
  • Collect signed new or updated CVs and job descriptions and upload them to the associated job title in the eQMS.
  • Perform additional duties as assigned.

Requirements

  • Bachelor’s degree in the life sciences or a related field, or relevant experience.
  • 5+ years of experience designing and managing GxP training curricula within an electronic QMS.
  • Experience with electronic learning management systems; Veeva experience strongly preferred.
  • Familiarity with FDA 21 CFR Part 11, ISO 9001, and GMP.
  • Excellent written and verbal communication skills with the ability to influence and build credibility at all levels.
  • Strong interpersonal skills for working across employees and leaders in multiple functions.
  • Strong attention to detail and ability to manage multiple processes and documentation requirements.
  • Advanced MS Office skills, including Word, Excel, and PowerPoint.
  • Strong organizational, prioritization, critical thinking, and decision-making skills in a fast-paced environment.
  • A continuous improvement mindset and willingness to learn and adapt to changing business and site needs.

Benefits

  • Base salary range of $105,000 to $128,000.
  • Annual performance incentive bonus.
  • New hire equity package.
  • Medical, dental, and vision insurance.
  • 401(k) match.
  • PTO and paid holidays.

Interested in this position?

Apply directly on the company website

Apply Now

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