[Hiring] Document Control Manager REMOTE USA

Position: Document Control Manager

Date Posted: November 18, 2025

Industry: Biotechnology / Life Sciences

Employment Type: Full Time

Experience: 5+ years in document control or related pharmaceutical area

Qualification: Bachelor’s degree in life sciences, chemistry, or related field; relevant experience considered

Salary: $85,000 – $125,000

Location: Minneapolis, MN, USA, REMOTE

Company: Celcuity

Description:

Celcuity, a clinical-stage biotechnology company, is seeking a highly skilled Document Control Manager to report to the Director of Quality Management Systems. This role is essential for managing the creation, revision, and administration of controlled documents and ensuring compliance across the company’s Content Management System for research records.

Key Responsibilities:

  • Facilitate creation, revision, and retirement of controlled documents in the eDMS, managing Document Change Control workflows.
  • Coordinate migration and management of legacy files into the eQMS.
  • Work with the Training Admin to update Training Requirements, learners, quizzes, and other training linked to controlled documents.
  • Assist eDMS users in document creation and revisions; collaborate with QMS Admin to maintain SOPs and Work Instructions.
  • Ensure employees can locate and utilize current effective documents.
  • Lead meetings with QMS Admin and document reviewers to finalize content creation or revisions.
  • Manage GxP record retention, destruction, and Certified Copy creation.
  • Perform additional duties as assigned.

Qualifications and Skills:

  • Bachelor’s degree in life sciences, chemistry, or related field.
  • 5+ years of document control experience in pharmaceuticals or similar industry.
  • Proficiency with electronic document management systems (Veeva preferred).
  • Strong knowledge of document lifecycle management, version control, and metadata tagging.
  • Familiarity with FDA 21 CFR Part 11, ISO 9001, GMP.
  • Excellent written and verbal communication skills with credibility across organizational levels.
  • Strong organizational, technical, and analytical abilities; adept at multitasking and prioritizing.
  • Advanced proficiency in MS Office (Word, Excel, PowerPoint).
  • Independent and team-oriented; flexible, adaptable, and committed to continuous improvement.
  • Positive, approachable, and professional attitude.

About Celcuity:
Celcuity develops targeted therapies to extend the lives of cancer patients, focusing on solid tumor treatments. Its lead candidate, gedatolisib, is a potential first-in-class PI3K/AKT/mTOR pathway inhibitor. Phase 3 clinical programs focus on HR+/HER2- advanced breast cancer, with ongoing trials for metastatic castration-resistant prostate cancer.

Benefits:

  • 401(k) plan with company match
  • Medical, dental, and vision insurance
  • Paid time off and holidays
  • New hire equity package
  • Annual performance incentive bonus

Compensation:
Base pay depends on candidate’s qualifications, experience, and location. The estimated range is $85,000 – $125,000.

Note for Recruiters/Staffing Agencies:
Celcuity does not accept unsolicited resumes from vendors without a formal agreement and will not be responsible for fees related to such submissions.

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