Director, IT Quality – Compliance

Apogee Therapeutics

Director of IT Quality & Compliance for Apogee, overseeing IT compliance and quality systems in a dynamic biotech environment. Collaborating with quality leadership and IT stakeholders to ensure top-tier regulatory operations.

Posted 5/19/2026full-timeRemote • 🇺🇸 United StatesLead💰 $220,000 - $245,000 per yearWebsite

Tech Stack

Tools & technologies

CloudCyber SecurityVault

About the role

Key responsibilities & impact

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
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
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
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

Requirements

What you’ll need

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

Benefits

Comp & perks

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
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
Regular all team, in-person meetings to build relationships and problem solve

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Veeva Vault QualityGxP compliancecomputer system validationIQ/OQ/PQ validation scriptschange controldocument controlCAPAtraining managementdeviation managementSaaS systems

Soft Skills

IT business partnertechnical advisorcommunicationcollaborationproblem-solvingproject managementstrategic planningrisk managementtraining deliveryvendor management

Certifications

GAMPCISAVeeva Vault certifications