Director, Quality Microbiology

Integra LifeSciences; Princeton (NJ); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Integra LifeSciences is seeking a Director of Quality Microbiology in Princeton. This role involves leading operational microbiology teams across various business sectors and ensuring compliance with quality standards in manufacturing.

The ideal candidate will have extensive experience in microbiology and strong leadership skills. Responsibilities include mentorship, global representation, and collaboration across various functions to meet company goals.

Qualifikationen

• 12 years of experience in medical device or regulated industry.
• 5 years of leadership experience in microbiology.

Aufgaben

• Lead and develop microbiology personnel.
• Ensure compliance with microbiology quality programs.
• Collaborate across functions globally.

Kenntnisse

Controlled environment qualification and monitoring

Bacterial endotoxin test method validation

Contamination control systems

Team leadership

Ausbildung

Master of Science degree in Microbiology

Bachelor’s degree in Microbiology

Jobbeschreibung

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Summary

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.

Essential Duties and 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

Required Experience

• 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.

Preferred