The position will play a key role in the deployment and maintenance of the digitalization/automation project (=iLABs or paperless labs) and the development of the lab data strategy for the JSC labs. The laboratory mission is to increase lab reliability through automation of processes and reduction in manual transcription of data, improved electronic control and data capture, delivering data integrity and efficiency value using global lab systems and interfaces.
The position is responsible for the development, qualification and maintenance of system and instrument interfaces with eLIMS. The position is responsible to align data structures of the different Lab Systems to improve accessibility of data and compliance and manage implementation and innovation projects related to this topic.
The position is responsible to lead complex lab systems projects.
The position is responsible to establish and provide leadership to customer network teams linked to lab systems, drive harmonization and continuous improvement with the ultimate goal of creating global, lean and standardized processes that enable the business to operate in the most optimal way.
The position collaborates with business partners, customers, DPDS, suppliers and IT to understand and assess customer requirements, translate these into strategic direction for system and data solutions, drives harmonization and lean solutions in the lab environment while ensuring compliance.
The position will proactively work with vendors and drives supplier technology platforms towards optimal customer satisfaction and optimal lab system configuration including master data.
The position is responsible to lead, guide and support internal teams and local site SME’s without direct reporting line.
A minimum of a bachelor’s degree required. An advanced degree (engineering) is preferred. A PE certification is preferred. A minimum of 10 years of experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) is required. Working knowledge of the business environment inside a quality organization, across various roles (e.g., quality operations, quality control, quality systems, etc.) is preferred. Extensive knowledge of lab environment is preferred. Demonstrated knowledge of applicable regulations (e.g., FDA, ICH Q8, 9, 10) is required. Demonstrated experience directly and/or indirectly leading a group of professionals to achieve business objectives is preferred. Excellent negotiation, partnering and influencing skills are required. Direct working knowledge of the business environment outside of the quality organization (e.g., manufacturing, product / process development, technical services / engineering, customer service, etc.) is preferred. Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style required. Demonstrated strategic thinking capabilities, ability to define a vision for the future required. Ability to translate vision to strategy, and strategy to execution required. Ability to build and nurture strong, positive relationships with business leadership, customers and partners in Global Quality Systems, DPDS, IT, Manufacturing, Regulatory Affairs and other Quality functional groups required.
Travel up to 20% is required.
North America-United States