QC Manager, Microbiology

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve.

Join us in our mission to improve patient outcomes through excellence in every aspect of our work.

• Provide leadership and operational oversight of a team responsible for routine microbiological testing supporting the release of product and process samples, including compendial and non-compendial microbiological assays used to ensure product quality and process control.
• Lead and develop a team of QC Microbiology colleagues, fostering a culture of safety, compliance, accountability, continuous improvement, and colleague engagement.
• Establish team priorities and manage performance through goal setting, coaching, talent development, succession planning, effective deployment of resources, and ongoing assessment.
• Drive operational excellence through the application of continuous improvement principles, including standard work, visual management, process optimization, and effective problem solving.
• Ensure compliance with Pfizer Quality Standards, regulatory requirements, and current cGMP, maintaining an inspection-ready laboratory and supporting internal and external audits and regulatory inspections.
• Collaborate with Quality, Manufacturing, Technical Services, Supply Chain, and other site functions to support production schedules, investigations, strategic initiatives, and business objectives.
• Monitor laboratory performance through the use of metrics and trend analysis, identifying opportunities to improve compliance, efficiency, capacity, and customer service.
• Lead change initiatives, implementation of new technologies, process improvements, and strategic initiatives that enhance microbiology testing capabilities and operational effectiveness.

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
• Extensive knowledge of cGMP compliance requirements for Quality Control Laboratories
• Demonstrated experience in microbiological testing, laboratory operations, investigations, and change management activities supporting pharmaceutical manufacturing and quality operations.
• In-depth understanding of aseptic processing, contamination control principles, and microbiological quality systems.
• Demonstrated experience leading teams, projects, or laboratory operations.
• Strong problem-solving, organizational, leadership, and analytical skills with the ability to manage multiple priorities.
• Excellent written and verbal communication skills with the ability to effectively engage technical, quality, and business stakeholders.

• Knowledge in the application of statistical tools, root cause analysis, and/or six sigma methodologies
• Experience supporting microbiological quality control testing programs and audit/regulatory inspections.
• Experience with QC laboratory instrumentation, method lifecycle management, and troubleshooting of microbiological testing systems.
• Experience supporting implementation of new methodologies, and technology transfer activities from R&D or other internal functions.
• Experience managing projects and cross-functional initiatives involving moderate complexity, multiple stakeholders, and competing priorities.
• Demonstrated success developing high-performing teams through coaching, talent development, performance management, and succession planning.
• Demonstrated ability to identify, implement, and sustain operational improvements through the application of continuous improvement principles.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving, data analysis, communication, and productivity improvements. Demonstrated curiosity for exploring how these tools…