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

Role: Digital Product Manager leading the digitization of Deviations & Issue Management QMS processes within a biopharma manufacturing division. Main objectives: streamline Deviations and Issue Management workflows, migrate and integrate QMS systems (Veeva Vault, SAP S4 Hana, Appian, Trackwise), and enable data-driven decision-making. Responsibilities include defining product vision and roadmap, translating business needs into technical requirements, leading large-scale cloud implementations, managing cross-functional teams, ensuring GxP compliance, and developing AI/ML capabilities for process optimization. Qualifications: Bachelor's in science, engineering, or related; at least 10 years' experience in pharmaceutical or regulated environments; proven track record in system implementation, process improvement, and digital enablement; strong knowledge of QMS systems, GxP regulations, and SDLC. Preferred: 5+ years at GMP manufacturing sites, experience with Deviations and regulatory processes, and advanced degrees. High-Value: focus on Deviations & Issue Management, cloud platform deployment, GxP compliance, AI/ML integration, and cross-divisional collaboration. Work setup: hybrid remote in US with ~10% travel.