Serve as a trusted advisor to senior stakeholders, including Vice Presidents of Engineering and Operations, and Site and Quality Leaders.
Provide strategic leadership in developing and executing Operational Readiness Plans and Assessments, either in-house or as a consultant.
Lead large, complex capital facility projects with budgets exceeding $5M.
Demonstrate deep understanding of Operational Readiness stage-gate processes and clearly articulate these to stakeholders and clients.
Lead cross-functional Operational Readiness teams in both internal and consulting environments.
Possess end-to-end knowledge of capital project execution, from design through start-up, including effective handoffs between Capital Project Execution and End User Operational Readiness teams.
Lead cross-functional teams (Engineering, Operations, Quality, Supply Chain) from Operational Qualification (OQ) completion through initiation of PPQ batches.
Maintain strong knowledge of biopharmaceutical manufacturing facilities, including Drug Substance and Drug Product/Packaging operations.
Lead and manage all start-up readiness elements, including consumables and raw material planning, engineering asset induction, and CMMS configuration and implementation.

Bachelor’s Degree (and/or Masters) in Life Sciences, Engineering, Regulatory or related discipline OR a combination of equivalent experience in quality assurance, cGMP facility start-up, regulatory assurance, relevant military and/or professional services.
8-14+ years directly relevant experience required
Minimum 7+ years’ Bio-Pharmaceutical industry experience
Capital Projects experience in a GMP pharmaceutical environment
Operational experience moving from capital execution to true facility start-up
Willingness to travel as required to support project and business needs.
Black Belt certification in Operational Excellence or Six Sigma preferred.

Operational Readiness Manager

Key skills