Job Title: Senior Manager Quality Control

Work Location: Middlesex County, Massachusetts

Summary:

The Senior Manager Quality Control oversees microbiological quality control activities for multiple programs and manufacturing operations. This role provides technical and operational leadership, ensuring laboratory testing is accurate, efficient, and compliant with GMP regulations and regulatory requirements. The position collaborates with cross-functional teams to support development, technology transfer, and manufacturing, while maintaining a focus on quality, compliance, and continuous improvement.

Responsibilities:

• Direct daily operations of the QC Microbiology laboratory, ensuring timely and compliant testing for raw materials, in-process samples, finished products, and environmental monitoring.
• Establish laboratory priorities, allocate resources, and monitor performance, workload, and turnaround times to meet manufacturing and regulatory requirements.
• Oversee environmental monitoring programs, author EMPQs, and manage microbiological testing of water systems and clean utilities.
• Lead investigations related to OOS, OOT, deviations, laboratory errors, and microbiological quality events, ensuring thorough documentation and timely completion.
• Maintain GMP and regulatory compliance for all QC Microbiology activities, support audits and inspections, and ensure data integrity in laboratory documentation.
• Mentor and develop QC Microbiology staff, fostering a culture of quality, compliance, and continuous improvement, and supporting hiring, onboarding, and training.
• Collaborate with cross-functional teams to resolve operational challenges, support root cause analysis, and implement corrective and preventive actions.
• Stay current with industry regulations and best practices, and support continuous inspection readiness and quality system initiatives.

Qualifications:

• Bachelor's degree in Microbiology, Biology, or a related scientific discipline required; Master's degree preferred.
• Minimum of 8 years of experience in pharmaceutical, biotechnology, CDMO, or other GMP-regulated environments.
• Supervisory or management experience within a QC Microbiology function.
• Experience supporting clinical and/or commercial manufacturing operations.
• Strong background in environmental monitoring, microbiological testing, and sterility assurance.
• Proven experience leading investigations (OOS, OOT, deviations, CAPAs, change controls) and supporting regulatory inspections and audits.
• Expertise in microbiological method transfer, validation, verification, and implementation.
• Comprehensive knowledge of GMP microbiology laboratory operations, regulatory requirements, and data integrity principles.
• Excellent technical writing, documentation review, and investigation skills.
• Demonstrated leadership, cross-functional collaboration, and problem-solving abilities.
• Strong verbal and written communication skills.
• Ability to work in both office and laboratory environments, including GMP-controlled areas, and comply with safety and quality requirements.
• Physical ability to sit, stand, lift up to 25 pounds, and use laboratory equipment and computer systems as required.

Published Category: Quality & Validation