Senior Sterility Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Provides specialized technical insights, guidance, and recommendations to the President of OEM regarding Sterility Assurance, Microbiology, Biocompatibility, and Toxicology.

• Accountable for ensuring compliant quality systems for Sterility Assurance, Microbiology, Biocompatibility, and Toxicology that align with applicable standards and OEM business requirements.

• Responsible for overseeing all technical elements involved in establishing, validating, maintaining, and managing sterilization processes - EO (cycle development, residuals, parametric release) and Gamma & E-beam (dose setting, auditing, dose mapping) in accordance with applicable standards for products at relevant facilities.

• Ensure thorough investigations of sterilization failures and implement effective corrective and preventive actions (CAPAs).

• Lead all technical efforts related to establishing, validating, maintaining, and managing a cleanroom environment in compliance with ISO 14644 standards (including bioburden testing, environmental monitoring (EM), and OOS/OOT investigations).

• Establish technical direction for the Sterility Assurance strategy in collaboration with business partners.

• Oversee toxicological risk assessments, including:

• Direct the biocompatibility program in line with relevant standards, including:

• Manage and support Quality Improvement initiatives in Sterility Assurance, consistently delivering enhanced value for all stakeholders by fostering a culture of excellence through continuous improvement.

• Collaborate with the Operations Procurement team to support Sterilization Supplier Quality Management.

⛳️ Requirements

• A minimum of a bachelor’s degree in a technical field is required; an advanced degree is preferred.

• At least 15 years of experience in a sterilization-related field, specifically within the medical device industry in RAQA / Engineering / Manufacturing environments, with a minimum of 5 years in a managerial role.

• Comprehensive knowledge and understanding of ISO 11135, 11137, 11138, 14644, and 10993 requirements, with expertise in achieving compliance.

• Demonstrated audit experience with various regulatory bodies/agencies.

• Experience working within a matrix management organization is essential.

• Exceptional communication skills with the ability to convey technical information clearly and concisely.

• Practical experience with aseptic sampling, EO, gamma/E-beam sterilization methods is essential; familiarity with steam, filtration sterilization, and aseptic filling processes is desirable.

🏝️ Benefits

• Medical, prescription drug, dental, and vision insurance.

• Flexible spending accounts.

• Participation in 401(k) savings plan.

• Various paid time off benefits, including PTO, short- and long-term disability, and parental leave.