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Senior Manager - Global Sterility Assurance

Apply Now Job ID R-328010 Date posted 01/25/2019

Job Description Summary

Job Description

Position Summary

Responsible for managing a team of sterilization professionals that deliver product sterility assurance for all finished medical devices, combination products and pharmaceuticals sterilized by a business segment. The role is accountable for all pre and post market sterility assurance activities inclusive of, but not limited to, production and process environmental control compliance, change control, QA release, sterilization validation/adoptions, process improvements, oversight of sterilization service suppliers (i.e Gamma, E-beam, ETO) and alignment to global best practices and standardization initiatives.

Essential Responsibilities

  • Actively manage, train and develop a staff of sterility assurance professionals dedicated to ensuring the product release, change control, validation/adoptions, contract management, experimentation and all associated activities deliver customer satisfaction through product quality, process efficiency, sterility assurance and national and international regulatory compliance. (30%)
  • Vigorously support the business by developing and maintaining open communication and connection with all business segment operators and laboratory staff responsible for executing the policies and procedures that ensure product sterility assurance. Enable problem solving, critical thinking, innovation and rapid issue corrections. (30%)
  • Provide technical backing and sterility assurance guidance to all business segment functions inclusive of, but not limited to, product development/sustaining engineering, regulatory affairs, sale, marketing, procurement and operations. (20%)
  • Keep self, staff and business segment current on ANSI, AAMI, ISO, USP, EPA and all other national and international standards that ensure product sterility assurance, employee safety and regulatory compliance. (10%)
  • Align to and drive for global standardization and harmonization specific to the policies, procedures and working instructions that produce product sterility assurance and regulatory compliance. (10%)
  • Delivers BDI product safety and compliance while driving for continuous improvements that strengthen P&L calculations. Ensure the sterility assurance quality management system is robustly compliant and yet adaptive to national and international regulatory demands.
  • Drives ongoing sterilization programs and projects for BDI harmonizing, where possible, the quality systems and processes used throughout BD. All changes to the BDI sterilization program should align within BD corporate quality goals, while maximizing BDI productivity and maintaining a high level of regulatory compliance.  
  • Assesses and builds BDI organizational capability through the training/development and qualification of personnel who perform process sterilization validations, monitoring of contamination, microbiological testing, sterile product release and technical assessments.
  • Actively supports BDI continuous improvement of the BDI sterilization program through leadership/participation in BD corporate sterilization networks.
  • Actively supports Technical Standards (e.g. AAMI, ISO, etc.) development in the areas of sterilization.
  • Conduct sterility assurance technical audits for BDI manufacturing sites and for contracted services.

Minimum Requirements

  • Bachelor’s Degree required
  • A minimum of 10 years relevant experience or a combination of equivalent education and relevant experience within a medical device/ pharmaceutical manufacturing facility having performed activities associated with sterilization and control of microbial contamination of products and processes.
  • Minimum 5 years of people management experience.Proven record of driving associates to achieve results.
  • Applied knowledge of regulatory, corporate or business required.
  • In depth knowledge of sterilization technologies and their associated guidance standards (11135, 11137, 17665, etc.).
  • Applied knowledge in ethylene oxide, irradiation &/or steam sterilization modes, at a minimum.
  • Applied knowledge of microbiological labs, controlled environments and sterile barriers.
  • Proven ability to lead, develop and manage people. 
  • Experience in the validation of two or more sterilization modes.

Preferred Qualifications

  • Certification in Black Belt / Green Belt in Manufacturing, Transactional Six Sigma or equivalent in ASQ Certification, desired  

#LI-OPS   

Primary Work Location

USA GA - Covington BMD

Additional Locations

USA NJ - Franklin Lakes

Work Shift

1st Shift 830am-5pm (United States of America)
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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com