QA Document Control Specialist

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.

Ideal Candidate

• Bachelor's degree or relevant comparable background (e.g., biology, chemistry, pharmaceutical sciences).

• Minimum of 3-5 years’ Quality Assurance (QA) experience within the biotechnology or pharmaceutical industry, with 1-2 years’ direct experience within Veeva Quality Vault.

• Working knowledge of electronic document management systems; Veeva Quality Vault required.

• General knowledge / experience in document control, data processing, and Computer System Validation (CSV) processes related to GXP document control and training systems.

• Strong attention to detail and a commitment to maintaining accuracy and compliance required.

• Proficiency in Microsoft Office (e.g., MS Word, MS Excel, Teams, SharePoint), Adobe Acrobat and Smartsheet.

• Exceptional organizational, communication, and problem-solving skills.

• Ability to work in a fast-paced and nimble environment with a rapidly growing organization, while handling multiple priorities and projects.

• Ability to collaborate and work effectively with cross-functional teams.

• Familiarity of GXP regulatory requirements and quality standards.

• Emerging leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment.

• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless.

• Ability and willingness to travel up to 10% (approximately 3-6 times per year for company meetings).

The anticipated salary range for candidates for this role will be $85,000 - $100,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

What We Offer

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless

• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave

• Commitment to growing you professionally and providing access to resources to further your development

• Apogee offers regular all team, in-person meetings to build relationships and problem solve

E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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