SAP, PMP, and ASCM/APICS Certified Supply Chain, Operational Excellence, & Quality Systems Leader with background in both biotech/pharma and measurement products.
Expertise strategically designing and/or optimizing manufacturing processes, regulatory / quality management systems, and procurement / logistics / supply chain programs both locally on-site as well as with a variety of consultancies and contract manufacturing organizations.
Effective site leader and project manager, directing teams involved with internal/external global cross-functional projects (i.e. product launch, tech transfer and continuous improvement) with financial responsibility up to $500M USD.
Developed strategic short- and long-term operational plans (including clinical programs and launches) for four global product lines with a variety of indications, distribution channels, and differing product lifecycle stages, then delivered favorable financial results according to those plans by overseeing all aspects of associated business processes (S&OP, Source-to-Pay, Forecast-to-Produce, and Order-to-Cash). As site leader, also cultivated an engaged workforce committed to embedding a culture of quality and continuous improvement throughout all levels of the organization.
Managed the translation of sales forecasts into actionable production and materials procurement plans for both internal and EMO production; highlighting and mitigating various business risks and opportunities. Acted as subject matter expert for numerous supply chain activities and projects related to continuous improvement, supplier quality, warehouse management, inventory control, purchasing, logistics, and planning.
· Led the supply chain arm of site tech transfer, site decommissioning, and site restart / ways of working projects
· Supported launches of SAP ERP for new acquisitions as well as the global implementation of S/4 HANA system upgrade
· Acted as site SME for sitewide SAP System implementation project (MM, PP, WM, QM, PM, & FI modules) and led all subsequent hyper-care, training, role management, and continuous improvement work
· Spearheaded global launch planning activities on-time for products both internally and with EMO/CMO partners
· Developed and/or optimized reporting tools for several Quality and Supply Chain departments
Performed supply chain, materials management, and quality functions with a focus on highlighting and implementing opportunities for financial cost savings and operational improvements. Managed a team of 15+ employees in daily manufacturing operations for the actuators & positioners product line. Simultaneously led a team of 3 employees performing any sitewide quality inspection/compliance tasks as well as all incoming, in-process, and outgoing quality assurance activities.
Managed development of daily production schedules and assignments for 55+ technician workforce; coordinated all contract employee activities; administered departmental HR activities; primary point of contact for processing and quality questions; led Six Sigma initiatives for franchise capacity expansion; implemented regulatory and investigational corrective/preventative actions (CAPA’s), validation protocols, and technological process changes; supervisor trainer and mentor.
Cross-Functional Site & Global Team Leadership / Talent Development
P&L Managemengt & Budget / 5YP Development
End-to-End Supply Chain Management
System Integrations, Tech Transfers, Acquisitions, and Site Closures
Operational Excellence (Lean/Six Sigma)
Global Product Launch Execution
Contract Manufacturing (CMO/EMO) Management
Clinical / Commercial Supply Planning
Quality Systems Optimizations & Development
Procurement & Source-to-Pay Optimization
Risk Management & Mitigation