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Digital Product Manager; Director; Deviations & Issue Management QMS Processes
Job in
Scranton, Lackawanna County, Pennsylvania, 18512, USA
Listed on 2026-09-05
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-05
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
IT/Tech
Data Analyst
Job Description & How to Apply Below
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/4
HANA). - 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.
- 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.
- 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.
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