QC Microbiology Lead: Quality, Compliance & Impact

Pfizer; Andover (MA); On-site; USD 106,000 - 177,000; Full time

Benefits offered by this job

Referral bonus eligibility

Job summary

Pfizer in the United States is seeking a QC Microbiology Leader to oversee routine microbiological testing ensuring product quality and process control. You will lead a team, drive safety and continuous improvement, and ensure compliance with regulatory standards.

You will collaborate with Quality, Manufacturing, and Technical Services to support production schedules and audits, while mentoring staff and maintaining an inspection-ready laboratory.

Qualifications

• 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 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.

Responsibilities

• Provide leadership and operational oversight of a team responsible for routine microbiological testing supporting the release of product and process samples.
• 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.

Skills

Leadership

Quality systems

cGMP knowledge

Microbiology testing

Investigations

Project management

Communication skills

Data analysis

Education

Bachelor's degree

Master's degree

Tools

Laboratory instrumentation

Job description

Pfizer in the United States is seeking a QC Microbiology Leader to oversee routine microbiological testing ensuring product quality and process control. You will lead a team, drive safety and continuous improvement, and ensure compliance with regulatory standards.

You will collaborate with Quality, Manufacturing, and Technical Services to support production schedules and audits, while mentoring staff and maintaining an inspection-ready laboratory.