Associate Director of Microbiology and Sterility Assurance

The Associate Director of Microbiology & Sterility Assurance is a quality leadership role responsible for overseeing microbiological practices and ensuring compliance with regulatory standards in our North Cove manufacturing facility. This position plays a critical role in ensuring product safety and efficacy through rigorous microbiological testing, risk assessment, and contamination control within the manufacturing site. The role provides expertise and guidance in interpreting government regulations, guidelines and internal requirements to ensure compliance. Develop and implement sterility assurance strategies, policies, and procedures for the manufacturing site. Develop and implement microbiology strategies, policies, and procedures including environmental monitoring, microbiological testing, and microbial identification; including identification of gaps, resolution of discrepancies, and development of action plans. Oversee the microbiology laboratory, including directing a team of microbiology professionals, scheduling, and prioritizing testing activities, and ensuring timely and accurate release of products. Ensure compliance with regulatory requirements and industry standards, such as FDA, EMA, PICs, USP and ICH guidelines. Assess impact of new regulations and implement appropriate changes as well as lead development of process flows and procedures. Maintain the company's sterile manufacturing operations, including cleanroom facilities, sterilization processes, and aseptic processing techniques. Provide direct supervision of individuals including mentoring, performance management and staffing decisions. Ability to lead a large team of employees. Conduct risk assessments and root cause analyses for sterility assurance and microbiology issues and develop corrective and preventive actions to address them. Develop and maintain positive relationships with cross-functional teams, including manufacturing, quality control, and research and development, to ensure effective communication and coordination of microbiology activities. Collaborate with cross-functional teams to ensure effective communication and coordination of sterility assurance activities. Participate in regulatory inspections and audits and respond to inquiries and observations from regulatory authorities. Handles department budget focusing on management of cost controls and cost reduction activities. Stay up to date with the latest industry trends, developments, and standard methodologies in sterility assurance and microbiology.