Associate Director, Sterility Assurance

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

About the role:
The Associate Director, Sterility Assurance, will serve as the global technical leader in design for sterilization in support of new product development across all divisions of BSC. You will have managerial responsibility for a high performing team of subject matter experts in sterility assurance, sterilization modalities, microbiological methods, device reprocessing and microbiological quality. You will build and maintain your and your teams state of the art knowledge and capabilities by actively networking with the internal and external scientific, technical and regulatory communities.

 

Your responsibilities will include:

• Influencing the company’s strategic and tactical directions and financial results globally through the application of technical leadership, knowledge, and expertise.
• Supporting new product development, collaborating with product teams and suppliers to provide design inputs as well as to validate sterile and microbiologically controlled products.
• Cross-functional collaboration and influence across multiple divisions and functions including quality, regulatory, global supply chain, and R&D.
• Developing strategies with respect to design for sterilization, sterilization modality selection, sterilization cycle design and product validation approaches.
• Providing input in the design of manufacturing processes, controlled environments and packaging from a microbiological standpoint.
• Conducting research into novel sterilization modalities, or novel applications of existing sterilization modalities and their impact on materials and product functionality and lethality.
• Interacting with external regulators and various levels of company management, working across many functional areas.

Required qualifications:

• Bachelor’s degree with Engineering, Microbiology, Biology, Chemistry or related discipline.
• 10+ years of experience in a medical device industry with a GMP and/or ISO regulated environment.
• 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 leve