Senior Sterility Manager

Position Summary

This position is responsible for Sterility Assurance. Sterility Assurance includes sterilization, environmental control, microbiological methods and processes, biocompatibility, and toxicology assessments and testing related to products either designed and/or manufactured by OEM. The role requires a senior strategic leader and technical expert who can manage a broad set of activities as described below.

Principal Responsibilities

•    Provides expert technical opinion, advice, and recommendations to the President of OEM regarding Sterility Assurance, Microbiology, Biocompatibility, and Toxicology.  
•    Responsible for ensuring compliant quality systems for Sterility Assurance, Microbiology, Biocompatibility, and Toxicology, meeting the applicable standards and OEM  business needs
•    Responsible for ensuring all technical aspects for establishing, validating, maintaining, and dispositioning sterilization processes - EO (cycle development, residuals, parametric release) and Gamma & E-beam (dose setting, auditing, dose mapping) are delivered per the applicable standards for products at the applicable facilities.
•    Ensure sterilization failures are investigated and implement robust CAPAs.
•    Leading all technical aspects of establishing, validating, maintaining, and dispositioning cleanroom environment to meet ISO14644 standards (Bioburden testing, Environmental monitoring (EM), OOS/OOT, etc)
•    Sets technical direction for SA strategy development in collaboration with business partners.  
o    Sterilization (EO, Gamma, E-beam)
o    Microbiology and contamination control
o    Biocompatibility and toxicology
•    Oversee toxicological risk assessments, including: 
o    Extractables & leachables evaluation
o    EO residuals toxicological impacts 
•    Lead the biocompatibility program with applicable standards, including: 
o    Biological risk assessments (BRA)
o    Test strategy development
o    Justification of test requirements

•    Manages and supports Quality Improvement projects in Sterility Assurance.  Constantly delivers improved value for all stakeholders by driving and developing a culture of excellence through continuous improvement.
•    Supports Sterilization Supplier Quality Management and partnership with the Operations Procurement team. 
•    Support supplier audits and ensure compliance with quality agreements.
•    Manages relationships with many stakeholders in different functions and locations. Provides leadership and direction in Sterilization methods to Development, Operations, QA, Procurement and other functions for New Product Development, and product, process and vendor changes.
•    Actively drives key talent development through coaching, mentoring, development assignments and other formal and informal actions and systems.
•    Serves as strategic member of the QARA team.
•    Ensures the focus of every employee within the Sterility Assurance function is on delivering the highest product and service quality standards to all our customers and their patients in a consistent manner and that the systems necessary to do so are in place.
•    Defines and recommends goals and objectives in Sterility Assurance. Develops specific short-term and long-term plans and programs, together with supporting budgets.
•    Ensures that necessary legal, regulatory and corporate compliance systems are in place and adhered to. 
•    Provide other departmental support as requested by immediate supervisor.
•    Adhere to and ensure the compliance of  OEM Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

•    Minimum education bachelor’s degree in a technical field, advanced degree preferred.
•    Minimum 15 years’ experience in a sterilization-related field, the medical device industry in RAQA / Engineering / Manufacturing/environment, with 5 years of managerial experience.   
•    Extensive knowledge and understanding of ISO 11135, 11137, 11138,14644 and 10993 requirements along with expertise in achieving compliance.
•    Proven audit experience for various regulatory bodies/agencies.
•    Experience in a matrix management organization is a must.
•    Excellent Communication skills with the ability to articulate technical information in a clear and concise manner.
•    Practical experience with aspectic sampling,  EO, gamma/ E.Beam  Sterilization methods essential,  steam, filtration sterilization, and aseptic fill processes desirable.

Specialized Skills / Other Requirements

PEOPLE LEADERSHIP

All people managers are responsible for the following: 
•    Organization Capability - Building organizational capability with a focus on developing the skills, knowledge, and potential of both individuals and teams. 
•    Cross-functional and Customer Alignment - Building cross-functional and Customer relationships and alignment is essential to driving coordinated, organization-wide success. Leaders must foster open communication, trust, and mutual respect. .
•    Continuous Improvement - Fostering a culture where learning, innovation, and adaptability are part of everyday work. Use of data and feedback to inform decisions and to recognize both progress and lessons learned. 

The pay range for this position at commencement of employment is expected to be between $152,000 – $229,000; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.