Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Global Director of Microbiology and Sterilization is responsible for setting goals and developing the strategies to support of S+N across all franchises and global sites for microbiology, sterilization and process cleaning.
What will you be doing?
This role provides strategic direction concerning quality and regulatory requirements regarding the science of microbiology relating to the sterilization and microbial control of medical devices. The Sr. Director of Microbiology is the primary interface for microbial control requirements per international and regulatory guidelines. The position interacts with our suppliers to ensure the necessary controls and validations are controlled for the sterilization of our products. The role supports multiple sites by providing the direction and testing of reusable devices in the area of cleaning and sterilization. The role provides direction as needed in the problem prevention and problem solving for all S&N locations in the area of microbiology. This position interacts with New Product Development to identify and validate processes necessary for the sterilization of new products. The role is the primary resource for local and international regulatory teams in the area of sterilization and microbiology (e.g. ISO, FDA, Notified Bodies etc.).
Responsibilities:
Directly support, in conjunction with Franchise leaders, the implementation of a global sterility assurance quality system program for all manufacturing sites.
Work within cross functional teams to determine microbiological cleanliness and control requirements for new products.
Oversee Implementation of microbiological control programs for new products at the manufacturing facilities and follow up on the effectiveness of the program.
Lead the standardization of requirements for manufacturing-controlled environment programs, systems, procedures, testing requirements and test methods.
Oversee the investigations of microbial OOS results and/or unfavourable trends.
Support the implementation of corrective preventative actions and follow-up on effectiveness of the actions.
Provide oversight of new facility/product qualifications where environmental controls are required.
Ensure efficiency, accuracy, and standardization within all the manufacturing sites for the procedures, testing requirements and test methods to support sterility assurance program requirements.
Function as reviewer and/or approver for the local procedures of the individual manufacturing sites to assure their compliance and alignment with the global corporate procedures.
Responsible for creating and implement a training program for all existing employee to support the quality system and quality control operations with the understanding on sterility assurance requirements.
Actively participate in and/or facilitate internal and external audits of the manufacturing facilities and external contract sterilizers for compliance to controls required for the sterilization process of medical devices products.
Location: Andover, MA, Memphis, TN, Fort Worth, TX, US Field/Remote
Education: Bachelor of Science degree in a scientific discipline or in life sciences required. Advanced degree preferred
What will you need to be successful?
- 10+ years of experience in the medical device or pharmaceutical industry required with at least 5 years' experience in a leadership role within Quality Assurance is required. Direct experience writing or developing validation programs experience required. A thorough understanding of the QSR and ISO regulatory environment.
- Requires organizational and time management skills.
- Organizational design and change management.
- An ability to work independently.
- Excellent verbal and written communication skills.
- Auditing skills required
- Leading a team (5-6 Direct reports / 35-40 indirect reports)
Travel: 10 - 15%
You Unlimited.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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