Digital Product Director: Deviations & QMS Transformation

Responsibilities:

• Digital Delivery Lead for implementation of Deviations Management & Issue Management Process into Veeva QMS Vault (migrate deviations process/data from Appian, UiPath, SAP ECC 6.0 to Veeva; integrate with SAP S/4
  
  Hana).
• Define and lead product vision/value map/roadmap for Deviations digital capabilities.
• Partner with site/manufacturing/technical operations SMEs and the Investigations Product Owner to translate strategy into IT/product initiatives.
• Own requirements and GxP documentation; lead product discovery and maintain prioritized product backlog.
• Drive end-to-end delivery of global cloud platform implementations; lead cross-functional matrixed teams and oversee product releases.
• Ensure SDLC- and GxP-compliant design/development/testing/operations.
• Champion IT standards/tools (JIRA, Confluence) and release/support planning; govern consistent global process design.
• Drive performance monitoring, metrics, and optimize TCO; lead AI/ML for Deviations.
• Serve as liaison with partners/vendors; advocate user-centered design; act as change agent.

• Bachelor’s degree in CS/engineering/biology/chemistry or related technical/scientific field.
• 10+ years pharmaceutical industry experience.
• Proven experience leading cross-divisional process improvement, system implementations, and cloud rollouts in regulated environments.
• Product backlog definition/prioritization experience.
• Leadership in cross-functional matrix organizations.
• Hands‑on knowledge of Deviations/Issue Management and QMS systems (Veeva Vault QMS, Trackwise, SAP, Appian).
• Experience with Deviations Management AI/ML/GenAI; partner with data science to operationalize models.
• GxP SDLC/validation/testing and regulatory compliance knowledge (21 CFR 210/211, ICH, FDA guidance).
• Strong communication, analytical/problem‑solving, and influence without authority.

• 5+ years at GMP manufacturing sites or site‑level Deviations exposure.
• 5–10+ years in Deviations/Root Cause Investigations/quality‑regulatory/digital enablement.
• Exposure to DS/DP/FDP end‑to‑end manufacturing, supply chain/logistics, QC, and GCP operations; global releases/multi‑region deployments; MS or MBA.

• Salary range: $–$; annual bonus/long‑term incentive if applicable; medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.