QC Microbiology Manager

A rapidly growing specialty pharmaceutical company is seeking an experienced Quality Control Microbiology Manager to lead all microbiological quality control activities and provide strategic oversight of the microbiology laboratory. This position is responsible for ensuring compliance with regulatory requirements, maintaining a state of inspection readiness, and driving continuous improvement across microbiology operations. Position Summary The QC Microbiology Manager provides leadership for all microbiological testing, environmental monitoring, contamination control, utility monitoring, and microbiological compliance programs. The role is responsible for laboratory staffing, budgeting, strategic planning, regulatory readiness, and operational excellence. The successful candidate will serve as the site's microbiology subject matter expert and work cross‑functionally to support product quality, patient safety, and business objectives. Position level will be commensurate with experience. Key Responsibilities Department Leadership Manage all QC Microbiology laboratory operations and personnel. Develop departmental goals, metrics, and strategic initiatives. Establish staffing plans and oversee hiring, training, performance management, and succession planning. Manage departmental budgets, resources, and laboratory capital projects. Compliance and Regulatory Oversight Ensure ongoing compliance with FDA, USP, cGMP, and applicable regulatory requirements. Maintain laboratory inspection readiness at all times. Lead microbiology support activities during regulatory inspections and customer audits. Approve microbiology investigations, CAPAs, change controls, and risk assessments. Technical and Scientific Leadership Serve as site subject matter expert for microbiology and contamination control. Provide oversight for environmental monitoring, utility monitoring, sterility assurance, and contamination control strategies. Review and approve method validations, method transfers, and qualification studies. Provide technical leadership for investigations involving contamination events, microbial recoveries, environmental excursions, and adverse trends. Continuous Improvement Develop and implement laboratory efficiency and automation initiatives. Evaluate and implement new technologies and rapid microbial methods. Drive continuous improvement and operational excellence programs. Establish and monitor key performance indicators (KPIs) for laboratory performance. Cross‑Functional Collaboration Partner with Manufacturing, Quality Assurance, Validation, Engineering, Regulatory Affairs, and Supply Chain teams. Support new product introductions, process validations, and facility expansion projects. Contribute to quality systems and site‑wide compliance initiatives. Knowledge and Skills Expert knowledge of pharmaceutical microbiology, sterility assurance, and contamination control. Extensive knowledge of USP microbiology requirements, FDA regulations, and cGMP standards. Strong leadership and organizational management skills. Experience leading regulatory inspections and responding to agency observations. Strong project management, budgeting, and strategic planning capabilities. Excellent communication and stakeholder management skills. Experience and Qualifications Bachelor's degree in Microbiology, Biology, or related scientific discipline required. Master's degree preferred. Minimum 8 years of microbiology laboratory experience. Minimum 3‑5 years of laboratory management experience. Demonstrated experience supporting FDA inspections and regulatory audits. Extensive experience with Sterility Testing, BET, MLT, Environmental Monitoring, Water Systems, PET, Method Validation, Disinfectant Qualification, Hold Time Studies, and Container Closure Integrity. Experience in sterile manufacturing, compounding, biologics, or specialty pharmaceutical environments strongly preferred. Benefits Competitive Pay Medical, dental and vision coverage Paid time off 401(k) savings plan Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process. #J-18808-Ljbffr Yoh,-A-Day-