Associate Director of Sterility Assurance

We are seeking an experienced leader to drive sterility assurance and contamination control strategy across a regulated sterile manufacturing environment. This is a remote opportunity at the senior management/associate director-level role with no direct reports, requiring the ability to influence cross-functional teams through technical expertise, sound judgment, and strong stakeholder engagement.Key ResponsibilitiesLead the development, implementation, and continuous improvement of the site's Contamination Control Strategy (CCS).Design and enhance environmental monitoring (EM) programs and contamination control initiatives across sterile manufacturing operations.Provide strategic technical leadership for aseptic processing, sterilization, and validation activities.Evaluate and lead investigations into contamination events across fill/finish operations as well as upstream manufacturing, including bioreactors and fermenters.Serve as the subject matter expert during inspections, audits, and complex technical discussions, promoting science-based, risk-focused decision making.Ability to travel on-site to Des Moines, Iowa region up to 50%.QualificationsBachelor's degree in Microbiology, Biology, or a related scientific discipline; advanced degree preferred.15+ years of experience in sterile manufacturing, biotechnology, pharmaceuticals, vaccines, or another highly regulated environment.Demonstrated success establishing contamination control strategies and implementing environmental monitoring programs.Deep understanding of aseptic processing, sterile barriers, contamination control, and microbial risk throughout the manufacturing process.Experience supporting investigations involving sterile manufacturing, bioreactors, fermenters, and aseptic operations.Strong knowledge of current GMP requirements and contamination control best practices.If this sounds interesting, please apply or share your resume to suhaillah.haqq@jcwgroup.com and let's find a time to chat!