Establish and maintain the global governance framework for OT partners, including strategic platform providers, strategic suppliers and shared service delivery models.
Define roles, responsibilities, and interfaces between Tier 1 partners, shared services, and internal teams to avoid overlap and gaps.
Ensure partner governance practices (reviews, escalations, approvals) are consistently applied across all regions and sites.
Drive adherence in collaboration with DQ and CSV to GxP, safety, and regulatory expectations in all partner-delivered services and projects.
Design and oversee the shared services structure for OT partner-delivered services (run, maintain, enhance) across PCS, MES, OSI PI, LIMS, and related platforms.
Define the global OT service catalog, SLAs/KPIs, and RACI for internal teams, shared services, and external partners.
Monitor service performance data and drive improvements in reliability, responsiveness, and quality of shared and partner-delivered services.
Own and maintain global master service agreements, quality plans, service agreements, and maintenance agreements for strategic OT partners and shared services.
Develop, standardize, and continuously improve project contracting templates for use across all OT platforms and project types.
Oversee partner project delivery quality for OT-related operational and capital projects, ensuring adherence to global standards, templates, and governance.
Requirements
Bachelor of Science in an Engineering, Automation, Computer Science or local equivalent.
10+ years’ work experience, with at least 5 years’ experience in execution systems, operational technology, IT and operations
Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95)
Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, DCS, MES, PAT, LIMS, Digital Methods, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environment.
Experience writing, executing, and monitoring automation contract deliverables.
Ability to work across a range of countries and cultures.
Strong project management skills and experience in engineering projects within biopharma manufacturing.
Functional knowledge of cGMPs and manufacturing operations in FDA-regulated facilities.