Digital Product Manager – Deviations & Issue Management QMS Processes

• Lead digitization of the Deviations QMS process within the Quality Management System
• Lead implementation of Deviations Management and Issue Management processes into Veeva QMS Vault
• Migrate Deviations QMS processes and data from Appian, UiPath Solutions, and SAP ECC 6.0 to Veeva Vault QMS, integrating with SAP S/4
  
  HANA
• Define and lead the product vision, value map, and roadmap for Deviations digital capabilities
• Translate business strategy into prioritized IT and product initiatives with subject-matter experts and the Investigations Product Owner
• Own requirements definition, business-to-development translation, and GxP system documentation
• Lead continuous product discovery and maintain a prioritized product backlog
• Drive end-to-end delivery of large global cloud-platform implementations in pharma/life sciences
• Lead cross-functional, matrixed teams and oversee less senior team members
• Ensure systems are designed, developed, tested, and operated in SDLC- and GxP-compliant ways
• Govern global process design for Deviations digital solutions
• Align investment and portfolio planning with business and technology leaders
• Monitor performance, develop metrics, and optimize total cost of ownership
• Lead design and delivery of AI/ML capabilities for Deviations processes
• Liaise with technology partners, vendors, and stakeholders
• Advocate for user-centered design and connect delivery squads with end users
• Influence stakeholders, manage conflicting priorities, and support adoption of new ways of working

• Bachelor’s degree in computer science, engineering, biology, chemistry, or a related scientific/technical field
• Minimum of ten (10) years’ experience associated with the listed required skills within the pharmaceutical industry
• Experience leading cross-divisional large and complex process improvement initiatives, system implementations, and cloud platform rollouts in regulated environments
• Experience defining and prioritizing product backlogs and collaborating with development teams
• Leadership of cross-functional internal and external teams in matrix organizations
• Hands-on knowledge of Issue Management and Deviations processes and relevant QMS systems, including Veeva Vault QMS, Trackwise, SAP, and Appian
• Experience developing, implementing, or managing Deviations Management AI/ML/Gen AI solutions and partnering with data science teams to operationalize models
• Strong working knowledge of SDLC practices for GxP systems, validation/testing, and regulatory compliance, including 21 CFR 210/211, ICH, and FDA guidance
• Exceptional verbal and written communication skills
• Strong analytical and problem-solving skills
• Ability to influence without direct authority, manage change, and work effectively in ambiguous, fast-moving environments
• Preferred: minimum of five (5) years working at GMP manufacturing sites, technical operations, or other site-level roles with hands-on exposure to Deviations processes
• Preferred: five or more (5–10+) years in Deviations, Root Cause Investigations, quality/regulatory, and digital enablement roles
• Preferred: experience with DS, DP, FDP End to End Manufacturing, Supply Chain & Logistics, QC Operations, and GCP Operations
• Preferred: prior experience with global releases and multi-region deployments in pharma/life sciences
• Preferred: advanced degree (MS or MBA) in a scientific, engineering, or technical discipline
• No visa sponsorship
• 10% travel required

Demonstrates expertise in leading the digitization of Quality Management System processes, particularly in Deviations Management and Issue Management within regulated environments. Proficient in managing cross-functional teams, product backlog prioritization, and ensuring compliance with GxP and SDLC practices.

• Veeva Vault QMS
• Deviations Management
• Issue Management
• GxP Compliance
• AI/ML Solutions

• Process Improvement
• Cloud Platform Implementation
• Product Backlog Definition
• Regulatory Compliance
• Data Migration
• SDLC Practices
• Validation/Testing
• Root Cause Investigations
• Deviations Processes
• Analytical Problem-Solving

• Exceptional Communication
• Influencing Without Authority
• Change Management
• Team Leadership
• Stakeholder Management

• Pharmaceutical Industry
• GMP Manufacturing
• Quality Management System
• Regulated Environments
• Global Releases

• SAP S/4
  
  HANA
• Appian
• UiPath Solutions
• Trackwise
• AI/ML Technologies