Senior Sterility Manager

Teleflex•Jaffrey, NH

6d•$152,000 - $229,000

About The Position

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.

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 aseptic sampling, EO, gamma/ E.Beam Sterilization methods essential, steam, filtration sterilization, and aseptic fill processes desirable.

Nice To Haves

Advanced degree preferred.
Steam, filtration sterilization, and aseptic fill processes desirable.

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.
Oversee toxicological risk assessments, including: Extractables & leachables evaluation, EO residuals toxicological impacts.
Lead the biocompatibility program with applicable standards, including: Biological risk assessments (BRA), Test strategy development, 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.