Director IT Quality & Compliance

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 Director, IT Quality & Compliance to serve as the primary IT business partner for Apogee’s Quality organization while owning the company’s IT compliance and validation function. This role sits at the intersection of IT and Quality: managing Veeva Vault Quality as the IT system owner, authoring computer system validation (CSV) scripts and protocols in partnership with QA, driving inspection readiness from the IT side, operationalizing AI governance compliance, and maintaining the IT policy library and vendor risk program. This role reports to the Senior Director of Digital Strategy & Enterprise Architecture.

Key Responsibilities

Quality IT Business Partnership

• Serve as the dedicated IT business partner for the Quality organization; develop a deep understanding of QA processes, priorities, and roadmap to anticipate and address IT needs proactively
• Own Veeva Vault Quality (QualityDocs and associated modules) as the IT system owner: manage system configuration, user administration, release management, and enhancement delivery in partnership with QA stakeholders
• Translate Quality business requirements into system enhancements, workflow changes, and configuration updates; manage the enhancement backlog and release cycle in coordination with QA and vendors
• Advise Quality on system risk, compliant use of technology, and IT implications of process changes; serve as a trusted technical advisor on how systems can best support quality operations
• Participate in QA planning meetings and strategic initiatives to ensure IT capabilities and constraints are represented from the outset

Computer System Validation (CSV)

• Author validation scripts, test protocols, and supporting documentation (IQ/OQ/PQ) for GxP-regulated systems including Veeva Vault, SAS Validated Cloud, Egnyte GxP, and validated MuleSoft integrations; partner with QA for CSV review and approval
• Assess system changes for validation impact; manage change control documentation and ensure validated systems are maintained in a compliant state following changes
• Conduct and document periodic reviews of validated systems; manage decommissioning procedures in line with regulatory requirements

Inspection Readiness & IT Compliance

• Own IT inspection readiness across the validated systems portfolio.
• Partner with QA to ensure IT systems and electronic records meet 21 CFR Part 11 and other regulatory requirements; lead IT response to inspection findings and drive remediation to closure
• Maintain audit-ready evidence packages for GxP systems: audit trail integrity, access control records, system configuration documentation, and change history
• Own the IT policy library: author, version, and maintain SOPs and policies covering electronic records, audit trails, access control, change management, data classification, and AI use
• Develop and deliver IT compliance training; maintain training records in validated learning management infrastructure

Vendor Risk Management

• Manage the IT third-party risk management program: vendor tiering, GxP qualification assessments, data handling reviews, and ongoing oversight for technology suppliers and SaaS providers.
• Evaluate new technology and AI vendors against Apogee’s governance framework prior to onboarding; coordinate security assessment inputs with the Director of Cybersecurity

Ideal Candidate

Required

• 8+ years of experience in IT quality systems, GxP IT compliance, or computer system validation in a regulated life sciences environment (biotech, pharma, or medical device)
• Demonstrated experience as an IT business partner or system owner for a Quality organization; deep familiarity with quality processes including document control, change control, CAPA, training, and deviation management
• Hands-on experience administering and configuring Veeva Vault Quality (QualityDocs required; additional modules such as QMS, Training, or RIM a plus)
• Hands-on experience authoring IQ/OQ/PQ validation scripts and protocols for GxP-regulated SaaS and cloud-hosted systems; comfortable working in a model where QA holds approval authority
• Working knowledge of 21 CFR Part 11, Annex 11, GAMP 5, and ICH standards as applied to IT systems
• Experience with inspection readiness and serving as an IT representative during FDA or EMA regulatory audits
• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or related field required; advanced degree or certifications (GAMP, CISA, Veeva Vault certifications) a plus

Preferred

• Familiarity with AI governance frameworks or AI/ML compliance considerations in a regulated environment
• Experience building or contributing to a Third party risk management program, including GxP vendor qualification
• Experience validating modern data platforms (Databricks, Snowflake, or equivalent) in a GxP context
• Background in clinical-stage biotech navigating Phase 3 and commercial readiness.

Behavioral Competencies

• Strong relationship-building skills; able to operate as a trusted partner to Quality leadership while maintaining IT rigor and objectivity
• Detail-oriented with strong documentation discipline; able to produce audit-ready deliverables under time pressure
• Comfortable operating at the intersection of regulatory, technical, and business domains with competing priorities
• High ownership and bias for action in a fast-paced, high-growth clinical-stage biotech environment

Other Requirements

• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 20%

The anticipated salary range for candidates for this role will be $220,000-$245,000/ 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.

A pogee 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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