Manager, Analytical Lab Systems Delivery
Manager, Analytical Lab Systems Delivery
Location: Morrisville, NC (some occasional travel as needed)
Type of role: FTE (salaried, full-time)
*The successful candidate will have a strong background with Waters applications (Empower 3, NuGenesis SDMS, and NuGenesis LMS) and has validated and deployed global systems in a regulated environment with knowledge of the applications and the more technical IT infrastructure knowledge.
This position is responsible for leading the definition, development and delivery of various global, harmonized and standardized laboratory/analytical processes to be implemented as part of the evolution of the Global Laboratory Automation (GLA) IT roadmaps. Position will play a key leadership role on the global implementation teams that will be responsible for defining standard global business processes, configuring/testing/validating the software solutions, and deploying the solutions across all sites. The position works closely with the business, consulting partners and internal IT teams serving as an expert resource, bringing forth opportunities to leverage core Analytical Systems and other complementary solutions to help support the growth of the business and influence decisions regarding business process changes.
• Works with the IT GLA leadership team to set the GLA direction and goals in alignment with the overall IT strategy related to the business processes.
• Works closely with the Operations and Quality organizations to develop standardized global business processes.
• Provides expertise and direction to the cross-functional implementation team that is responsible for the configuration, testing, and validation of GLA solutions along with system deployment activities across 30+ worldwide sites.
• Supports the Global Laboratory Automation Business Lead for GLA program delivery communications, organizational change management and the quality of all project deliverables.
• Works closely with the Master Data Management Data Governance and Application Leads to help develop and manage GLA solution-related data activities including interfaces, data conversions and general master data management. Reviews and provides input on subsequent formal deliverables including documentation and use of master data.
• Help identify vendors, products, and solution elements (programs, configuration, formal deliverable documentation and materials, etc.) that contribute to a highly effective solution.
• Ensures that deployed systems comply with all applicable company, GxP, legal, and fiduciary policies, practices and requirements.
• Ensures that processes are developed and implemented to effectively transition post-implementation support activities to the GLA Support Team.
• Leads and directs process team members in line with the goals of the GLA program. Encourages and facilitates cooperation, results orientation and collaboration among the team.
• Provides expertise and direction in various GLA processes and solutions including LIMS and Chromatography.
• Demonstrated track record of applying PM principles, practices and techniques.
• Strong results orientation. Sets and accomplishes challenging goals by leveraging team resources effectively. Takes calculated risks to achieve desired results.
• Strong partnership with the business community. Able to assess and develop strategies for achieving the needs of the user community. Seeks information about and identifies opportunities to support and enhance critical business functions and processes across the GLA portfolio. Defines and manages user expectations. Matches business requirements to new or existing products and services.
• Develops innovative solutions. Solicits information on enterprise direction, goals and the industry to determine how GLA can add value to the organization. Makes recommendations linked to the organization's strategy and financial goals.
• Drives growth. Identifies, documents, and monitors key business processes within the scope of GLA needed to achieve successful business results. Analyzes, maps and documents processes and develops a framework for process standardization and improvement.
• Bachelor’s Degree in Computer Science, Business Administration, or other related field or equivalent experience.
• 5+ years’ experience in implementing (LabVantage) LIMS and (Empower, OpenLAB, Chromeleon) Chromatography solutions in a global environment strongly preferred.
• Pharmaceutical and/or life sciences experience strongly preferred.
• Knowledge of industry trends, best practices & operating principles.
• Computer System Validation, 21 CFR Part 11 and general GxP experience preferred.
• Strong interpersonal, communication and problem solving skills.
• Travel of approximately 25% (as required by project assignments).