Director, Quality Microbiology

Integra LifeSciences•Princeton, FL

3d•Hybrid

About The Position

The Director, Quality Microbiology, is responsible for leading Integra LifeSciences operational microbiology teams across the Tissue Technologies and Codman Surgical Specialties businesses. Qualified candidates must possess relevant experience with Subject Matter Expertise in the following areas: Controlled environment qualification and monitoring, Water system qualification monitoring, Bacterial endotoxin test method validation and monitoring, Bioburden test method validation and monitoring, Contamination control systems (monitoring, gowning, aseptic techniques, cleaning, etc.). The candidate must be an experienced team leader who leverages the talent of their team to increase performance, generate results, and maintain robust quality of manufacturing site microbiology programs. This position reports to Corporate Quality Sterility Assurance and will be located in Princeton or another Integra facility with flexibility for travel as needed.

Requirements

Bachelor’s, or preferably Master of Science degree, in Microbiology or similar discipline.
Minimum 12 years’ experience in medical device or regulated industry with 5 years of leadership experience, with experience in microbiology.

Nice To Haves

Experience working with the manufacturing of tissue-based products and surgical tools as a microbiologist or similar scientific discipline in the medical device industry
Experience leading teams in the development and implementation procedures used in operations across multiple businesses/manufacturing sites.
Advanced communication skills (written and verbal) with the ability to curate information to a diverse audience of stakeholders
Robust cross-functional collaboration skillset with the capability of driving quality and operational excellence
Advanced team leadership experience including mentoring, meeting facilitation, coaching, influencing, and negotiation
Capable of working autonomously and with independence when needed while maintaining strong performance
Demonstrated capability to develop strategic direction, goals, and guiding execution in a team-based working environment
Advanced experience working within Quality Systems including, but not limited to, change control, CAPAs, deviations, nonconformances, risk assessments
Direct experience representing a department in regulatory inspections and communications
Advanced technical writing skillset with the capability to interpret and author complex documentation
Working knowledge of applicable microbiology standards including, but not limited to, FDA CFR, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, CMDR, Medical Device Directive, and USP.
Ability to travel up to 25%.

Responsibilities

Provide technical talent training, mentoring, and development support for microbiology personnel and cross-functional teams
Serve as a representative for microbiology globally and collaborate across functions such as quality, operations, R&D, Global Supply, Finance, Sales, and Marketing to ensure company goals are met
Act as a global process owner for microbiology and oversee the implementation of Global procedures to support compliance of Integra LifeSciences manufacturing site Microbiology Quality programs
Create and sustain long-term strategies and advise a team of managers and scientists across the Quality Microbiology team
Provide leadership and direction to the Quality Microbiology team to ensure business, quality, and compliance objectives are met
Report results of site microbiology programs to leadership for projects and key performance indicators
Resource business projects such as manufacturing transfer, acquisitions, new product development, etc. with microbiology personnel
Participate as a microbiology SME in internal audits, and external audits such as FDA inspections, ISO certifications, surveillance audits and customer audits.
Maintain a strong working knowledge of standards and regulations including FDA CFR, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, CMDR, Medical Device Directive, and USP.