Associate Director, Digital & Business Process Strategy

Key responsibilities

• Product vision and roadmap
• Define and socialize a compelling product vision linking MES (PAS-X, Tulip), Historian - CDZ, and LIMS capabilities to business outcomes (yield, cycle time, batch release, deviation reduction)
• Build and manage a multi-release roadmap, balancing global platforms with site needs, technical debt, and regulatory priorities.
• Maintain a prioritized, value-ranked backlog with clear acceptance criteria and Definition of Done.
• Stakeholder and value management
• Act as the voice of Operations, Quality, and QA/QP in product decisions; translate pain points into epics/features to deliver e2e business process maps and well-defined business requirements
• Quantify value through OKRs/KPIs (e.g., batch review time, exception rates, data availability SLAs) and track benefits realization.
• Delivery leadership
• Lead agile squads (process SMEs, solution architects, data engineers, MES configuration, historians, LIMS specialists, validation) to deliver increments.
• Capture and lineage from equipment and MES to historian and LIMS; expose governed data to analytics platforms.
• Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit readiness.
• Compliance and validation
• Ensure products comply with GxP, 21 CFR Part 11/Annex 11, data integrity (ALCOA+), and site/enterprise validation requirements.
• Data and analytics enablement
• Partner with Data & AI teams on use cases such as real-time deviation detection, golden batch, CPV/Continued Process Verification, and eBR/eBRR optimization.
• Operations readiness and lifecycle management
• Plan releases, cutovers, and change management across multiple sites; coordinate training and SOP updates.
• Own product performance, reliability, and cybersecurity posture; manage incidents, problem remediation, and continuous improvement.
• Manage vendor relationships (e.g., Körber, Factory Talk, PAS-X, Tulip, Historian and LIMS providers) and ensure contract deliverables align to roadmap.

Required qualifications

• Bachelor’s degree in engineering, life sciences, computer science, or related field; advanced degree preferred.
• 8+ years in pharma/biotech or highly regulated manufacturing with hands-on exposure to at least two of the following: PAS-X (or equivalent MES), process data historians (e.g., PI/AVEVA, IP.21, Ignition), LIMS/ELN.
• 3+ years as a Product Owner or equivalent (product management, solution owner) delivering digital capabilities in GxP environments.
• Strong understanding of manufacturing and quality processes: recipe management, eBR, batch disposition, deviation/CAPA, CPV, stability, and sample lifecycle.
• Demonstrated experience integrating shop-floor systems with enterprise platforms (ERP, QMS) and data/analytics stacks; familiarity with ISA-95/ISA-88 models and data standards.
• Practical knowledge of CSV/CSA, GAMP 5, data integrity, and audit expectations.

Preferred qualifications

• Experience with PAS-X configuration and content management; knowledge of interface frameworks, EBR review workflows, and exception handling.
• Background in OT/IT convergence: OPC UA, MQTT, edge connectivity, time-series data modeling, and event streaming.
• Working knowledge of modern data platforms and analytics (e.g., cloud data lakes, time-series services, visualization, ML for manufacturing).
• Certification in Agile/Scrum (PSPO, CSPO) and/or product management; Lean Six Sigma or equivalent continuous improvement credentials.
• Experience operating across multi-site/global manufacturing organizations and managing vendor ecosystems.