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:

• Responsible for strategic leadership and direction needed to develop, implement and maintain state of the art microbiology and sterilization assurance methods for Smith + Nephew using a well-grounded understanding of technical, scientific and regulatory issues.20 %
• Develops and oversees Global policies, procedure and training related to cleanrooms, sterilization, and reusable medical device cleaning programs to insure that they are in compliance with corporate, QSR, ISO, and other regulatory compliance requirements. 20 %
• Responsible for developing, implementing and general over sight of the validations, testing, and cleanroom controls relating to the sterilization processes used at the Smith & Nephew Memphis site. 10%
• Provide oversight to potential audit observations and manage audit related CAPA commitments relating to microbiology/sterilization as required. 5%
• Responsible for the review of sterilization contractors, controls and provides audit support for the microbiology/sterilization contractors. 5%
• Establishes the cleaning and sterilization guidance for reusable instruments. Establishes and oversees the validation of the reusable instrument cleaning and sterilization processes. 10%
• Provides oversight and guidance for sterilization options to ensure stable and cost effective sterilization options for Smith and Nephew product. 10%
• Interfaces and directs Product Development Engineers in determining appropriate sterilization methods for new products. Performs validations of the sterilization process for new products. 5%
• Supports Regulatory Affairs by providing responses to questions from FDA and Notified Bodies during audits and device filings. 5%

• 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.

• Inclusion, Diversity and Equity - We are committed to welcoming, celebrating and thriving on Diversity! Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/)
• Your Future: 401K Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: We offer Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

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.