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

Scorpion Therapeutics; Pennsylvania; On-site; USD 140,000 - 210,000; Full time

Job summary

Scorpion Therapeutics seeks a Digital Delivery Lead to drive Deviations Management & QMS initiatives, migrating data from Appian, UiPath, and SAP ECC to Veeva Vault QMS and integrating with SAP S/4HANA. You will shape the product vision, partner with operations SMEs, and translate business strategy into prioritized IT initiatives.

You will own requirements, lead global cloud implementations in regulated environments, and oversee cross-functional teams to deliver compliant, scalable solutions.

Qualifications

• Bachelor’s degree in a technical/scientific field.
• 10+ years in pharmaceutical industry with 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; 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.

Responsibilities

• Lead Deviations digital capabilities product vision and roadmap.
• Partner with SMEs and Investigations Product Owner to translate 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.

Skills

Product backlog prioritization

Cross-functional leadership

Regulatory compliance

GxP knowledge

Stakeholder communication

Education

Bachelor’s degree in technical/scientific field

Tools

Veeva Vault QMS

Trackwise

SAP

Appian

JIRA

Confluence

Job description

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.