Sterility Assurance - Associate Director

Builds and maintains state of the art knowledge and capabilities by actively networking with the internal and external scientific, technical and regulatory communities. Provides technical support to Global Sterilization Operations to ensure compliance to policies and standards relating to Sterilization and Sterility Assurance. Influencing the company's strategic and tactical directions and financial results globally through the application of technical leadership, knowledge, and expertise. Leads a team responsible for ensuring the qualification status of all BSC sterilization processes, investigations of process deviations and non-conformances, and analysis of the impact of changes to products and processes on sterility assurance Drives projects related to sterilization process expansion and optimization of major magnitude and scope Cross-functional collaboration and influence across multiple divisions and functions including quality, regulatory, global supply chain, and R&D Provides technical oversight and drives projects for continuous improvement in Sterility Assurance practices Interacting with external regulators and various levels of company management, working across many functional areas. Bachelor's degree with Engineering, Microbiology, Biology, Chemistry or related discipline. Minimum of 10 years of experience in a medical device industry with a GMP and/or ISO regulated environment. Minimum of 5 years of direct people leadership experience is required. Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility. Demonstrated capability to lead and train a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity. Experience in interacting with Regulatory Authorities. Demonstrated competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat). Proven track record on trouble shooting microbiological and/or sterilization process non-conformances and out of specification test results and providing resolution to issues via robust CAPA. High level knowledge of standards including AAMI and ISO. Must be able to travel 20% of the time (domestic and global) Master's or PhD degree in Microbiology, Biology, Engineering or related discipline. Competency in additional technical areas such as reprocessing and microbiology laboratory operations experience Experience with conducting technical assessments of in-house and contract sterilization processes or contract microbiological laboratories