Document Control Manager

Job not on LinkedIn

🕒 2 days ago

🇺🇸 United States – Remote

💵 $100k - $120k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 2%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Create, revise, manage, and retire Quality Systems documents within the eDMS • Manage controlled records, including historical records, within the controlled library • Manage and track Document Change Control workflows and participants • Migrate legacy files into the eQMS • Coordinate with the Training Admin on training requirements, learners, quizzes, and training related to controlled documents • Support eDMS users with document creation and revision procedures • Work with the QMS Admin to maintain document control SOPs and Work Instructions • Help eDMS users find and use current effective documents • Facilitate meetings with the QMS Admin and document reviewers for content creation and revisions • Manage GxP record retention and destruction tasks • Facilitate Certified Copy creation and retention • Perform other duties as assigned

🎯 Requirements

• Bachelor's degree in the life sciences, chemistry, or related field; or relevant experience • 5+ years of experience in document control in a pharmaceutical company, or a related area • Proficiency and experience with electronic document management systems; Veeva strongly preferred • Knowledge of version control practices and document lifecycle workflows • Familiarity with FDA 21 CFR Part 11, ISO 9001, and GMP • Strong attention to formatting, process, and metadata tagging; ability to create and correct Styles in Word strongly preferred • Document auditing and compliance tracking capabilities • Advanced knowledge of MS Office, including Word, Excel, and PowerPoint • Excellent written and verbal communication skills • Strong interpersonal skills • Attention to detail and ability to manage multiple processes and documentation requirements • Strong technical and analytical skills • Ability to work in a team or independently • Outstanding organizational and prioritization skills • Independent and sound decision-making skills; ability to think critically in a fast-paced environment • Continuous improvement mindset • Flexibility and willingness to learn and adapt to business and site needs • Positive, approachable, and professional attitude

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays