Director, Quality Microbiology

Role: Director of Quality Microbiology overseeing microbiology functions across Tissue Technologies and Surgical Specialties divisions. Responsibilities include leading microbiology teams, developing strategies, ensuring compliance with standards (FDA, ISO, USP), and representing microbiology in audits and cross-functional collaborations. Key tasks involve staff training and development, global process ownership, resource allocation for projects like manufacturing transfer and new product initiatives, and maintaining microbiology quality programs. Qualifications: Bachelor's or Master’s in Microbiology or related field; at least 12 years’ regulated industry experience with 5+ years in leadership, preferably within medical devices or tissue-based products. Skills include expertise in controlled environments, water systems, endotoxin and bioburden testing, contamination control, and strong knowledge of microbiology standards and regulations. Preferred attributes encompass leadership in multi-site operations, advanced communication, strategic planning, and experience in regulatory inspections. Work setup allows for location flexibility (Princeton or other Integra facilities), with travel up to 25%. High-value specifics: focus on microbiology in regulated medical device manufacturing, including contamination control systems, validation, and compliance with global standards.