QA Document Control Specialist

Apogee Therapeutics, Inc. - Common Stock

RemoteRemotePosted February 18, 2026

Job Description

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.

We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.

If this sounds like you, keep reading!

Role Summary

We are seeking a Document Control Specialist who will manage document control activities within the electronic document management system (EDMS) (i.e., Veeva Quality Suite), related to Phase III and Commercial readiness associated GXP (i.e., Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP)) documentation.

The successful candidate will play a critical role in ensuring that Apogee maintains the highest standards of document management and regulatory compliance and will support cross functional teams’ success in the advancement through every stage within the document lifecycle. This position will report to the Associate Director, Quality Systems.

Key Responsibilities

Document Control:
- Maintain document control policies, procedures, and systems in accordance with GXP regulations.
- Utilize Veeva Systems as a centralized EDMS for GXP documentation and employee training.
- Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records.
Quality Assurance:
- Conduct regular audits (“data cleaning”) of GXP documents and training processes and documents/records to identify, address, and correct discrepancies and or non-compliance issues to ensure accuracy and “system wellness.”
- Maintain robust quality control measures for all GXP documents.
Veeva Expertise:
- Leverage experience with Veeva Systems to optimize document management processes and workflows.
- Provide guidance and training to staff on using Veeva for document control and compliance purposes.
Regulatory Compliance:
- Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, EMA, ICH).
Cross-functional Collaboration:
- Work in partnership with various departments (e.g., Biometrics, Clinical, IT, Legal, Nonclinical, Program Management, Regulatory Affairs, Technical Operations, etc.) to ensure GXP document accuracy and relevance.
Continuous Improvement:
- Identify opportunities for improvements in GXP document and record control practices.