Celcuity

QMS Training Manager

Celcuity

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $105,000 - $128,000 per year

About the role

  • Manages curricula and learner roles, including periodic review of curricula, learner roles, and training requirements with department heads and QMS Admin.
  • Coordinates with study team leads to update study-specific training documents, routes for approvals, and manages study team learner role membership in the LMS.
  • Coordinates with document owners and Doc Control to create or revise Training Requirements with new or revised controlled documents and training materials.
  • Coordinates with hiring managers to launch Training Plans for new or changing learner roles.
  • Works with hiring managers and HR to review and approve onboarding forms.
  • Coordinates information about training and QMS orientation for new hires; adds new hires to appropriate training curricula and learner roles per their onboarding training plan.
  • Collects signed new or updated CVs and job descriptions and uploads them to the associated Job Title in the eQMS.

Requirements

  • Bachelor’s degree in the life sciences or related field; or relevant experience.
  • Five plus (5+) years of experience in GxP training curricula design and management within an electronic QMS. Veeva experience preferred.
  • Proficiency and experience with electronic Learning Management Systems, Veeva strongly preferred.
  • Familiarity with industry standards such as FDA 21 CFR Part 11, ISO 9001, GMP.
  • Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint.
Benefits
  • medical, dental, vision insurance
  • 401(k) match
  • PTO
  • paid holidays
  • annual performance incentive bonus
  • new hire equity package
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GxP training curricula designelectronic QMSLearning Management SystemsMS OfficeWordExcelPowerPoint
Soft Skills
analytical skillscoordinationcommunication