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

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.