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Apogeetherapeutics
Director, IT Quality & Compliance
qafull-timeRemote
SALARY
Not listed
WORK TYPE
remote
JOB TYPE
full-time
INDUSTRY
healthcare
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About the role
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
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