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Digital Product Manager (Director) - Deviations & Issue Management QMS Processes

Jobleads-US

Responsibilities Digital Delivery Lead for implementing Deviations Management & Issue Management into Veeva QMS Vault (migrate deviations QMS process/data from Appian, UiPath, and SAP ECC 6.0 to Veeva Vault QMS; integrate to SAP S/4HANA). Define product vision, value map, and roadmap for Deviations digital capabilities. Partner with site/manufacturing/technical operations SMEs and the Investigations Product Owner to translate business strategy into prioritized IT/product initiatives. Own requirements definition, business–development translation, and documentation for GxP systems. Lead continuous product discovery; convert findings into a prioritized product backlog. Drive end-to-end delivery of large global cloud platform implementations in pharma/life sciences. Lead cross-functional matrixed teams, oversee less-senior members, and be accountable for product releases. Ensure SDLC- and GxP-compliant design, development, testing, and operations. Champion IT standards/tools (JIRA, Confluence) and release/support planning; govern consistent global process design. Drive performance monitoring/metrics, optimize total cost of ownership (TCO). Lead design/delivery of AI/ML capabilities for Deviations; liaison with vendors/partners. Advocate user-centered design; facilitate connections between squads and end users. Act as change agent to manage priorities and enable adoption. Qualifications Required Bachelor’s degree in CS, engineering, biology, chemistry, or related technical/scientific field. 10+ years in pharmaceutical industry related to required skills. Experience leading complex process improvement/system implementations/cloud rollouts in regulated environments. Track record defining/prioritizing product backlogs; collaborating with development teams. Leadership of cross-functional teams in matrix organizations. Hands‑on knowledge of Issue Management & Deviations processes and QMS systems (Veeva Vault QMS, Trackwise, SAP, Appian). Experience with Deviations Management AI/ML/GenAI; partner with data science to operationalize models. SDLC/GxP knowledge; validation/testing and regulatory compliance (21 CFR 210/211, ICH, FDA guidance). Exceptional communication; present technical/regulatory concepts to senior/global stakeholders. Analytical/problem-solving; data-driven mindset. Influence without authority; manage change in ambiguous environments. Preferred 5+ years at GMP manufacturing sites/technical operations with hands‑on Deviations exposure. 5–10+ years in Deviations, Root Cause Investigations, quality/regulatory, and digital enablement. Exposure to DS/DP/FDP end-to-end manufacturing, supply chain/logistics, QC/GCP operations. Experience with global releases/multi-region deployments; MS/MBA. #J-18808-Ljbffr Jobleads-US

Vacancy posted 1 day ago
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