Sr. Mgr, Sterili Assur & Lab Ops

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary

The Senior Manager, Sterility Assurance & Laboratory Operations is responsible for managing sterility assurance and laboratory operations. They will develop and maintain compliant programs in the areas of sterility assurance, environmental monitoring, chemical and microbiology laboratory operations for all TMC manufacturing facilities. This individual will represent Terumo as a member of industry organizations in area of expertise.

Job Details/Responsibilities

• Manages and develops a team of professionals.  Establishes a high-performing team to drive the organizational goals & objectives and instill quality culture.  Drives engagement to ensure personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop and are recognized for their contributions.
• Provides leadership and technical direction for sterility assurance, microbiological methods, environmental monitoring.  Actively support new product development and life cycle management in area of expertise.
• Provide technical support for gamma sterilization processing operations in the Elkton, MD facility ensuring compliance with all applicable quality and safety regulations including maintaining compliance as a contract sterilizer.
• Manages laboratory operations (microbiology and chemistry) supporting manufacturing and new product development; including but not limited to chemical solution preparation, product release testing, and environmental monitoring.  
• Develops and directs the company’s sterility assurance program including but not limited to, dose settings, dose audits, ethylene oxide sterilization cycle development and qualifications/re-qualifications, sterilization adoptions, environmental control, bioburden process control and microbial characterization.  Sets technical direction for sterilization strategies for internal and external contract sterilization.
• Develops and directs the company’s environmental monitoring program including water, air, and product.  Includes responsibility for verification of environmental conditions and facility certifications related to manufacturing environmental requirements. 
• Drives functional excellence through continuous improvement. Continually examine the scope of testing services being performed to ensuring alignment with business needs and regulatory requirements.  Remain current on industry trends and drive changes to processes through the Strategic Quality Plan.
• Serves as technical expert in functional area for regulatory and external audits. 
• Qualifies and supports auditing of contract laboratories and external sterilization vendors.
• Perform other duties as assigned.

Knowledge, Skills and Abilities (KSA)

• Quality and business process knowledge
  • Working knowledge of national and international regulations applicable to medical devices including but not limited to 21 CFR 820, Canadian Medical Device Regulations, ISO 13485, MDSAP, EU MDR, and other global regulations.  
  • Extensive knowledge of standards and guidance’s related to terminal sterilization (ethylene oxide and gamma), cleanroom environmental controls, microbiological methods and biological safety.
  • Knowledge of terminal sterilization operations including demonstrated experience with development and validation of ethylene oxide and radiation terminal sterilization methods.
  • Knowledge of radiation safety regulations and ability to complete required radiation safety courses.
  • Ability to analyze and interpret regulatory guidelines and standards.
• Leadership skills:
  • Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership.  
  • Strong interpersonal skills to provide coaching, training, and direction. 
  • Demonstrated ability to provide clear direction and mentor personnel.   
  • Proven experience influencing across the organization to improve product or processes.     
• Individual skills required:
  • Strong proofreading and