Senior Manager, Quality Control

Meet Life Sciences Ltd.; Boston (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Meet Life Sciences Ltd. in Boston is seeking a Senior Manager, Quality Control Microbiology to lead microbiology QC operations across development, tech transfer, and GMP manufacturing.

You will ensure accurate testing, compliance with GMP, ALCOA+ data integrity, and readiness for inspections. The role combines technical leadership with people management, overseeing environmental monitoring, OOS/OOT investigations, CAPA, and change control while partnering with QA, Manufacturing, and Regulatory

Qualifications

• Bachelor's degree in Microbiology, Biology, or related discipline; Master's preferred.
• 8+ years in GMP regulated environment with QC Microbiology supervisory experience.
• Experience in environmental monitoring, sterility, aseptic processing, and utility monitoring.
• Strong leadership, technical writing, and communication skills; ALCOA+ data integrity.

Responsibilities

• Oversee QC Microbiology operations including raw materials, in-process, finished products, and EM.
• Manage priorities, staffing, capacity and turnaround to meet manufacturing schedules while ensuring GMP compliance.
• Oversee environmental monitoring, EMPQ, water testing, and aseptic process support.
• Lead investigations of OOS/OOT, deviations, contamination events; drive CAPA and change control.
• Mentor and develop QC Microbiology personnel; ensure inspection readiness.

Skills

Quality leadership

GMP knowledge

Environmental monitoring

OOS/OOT investigations

CAPA & change control

Regulatory inspections

Education

Bachelor's degree in Microbiology or related field

Master's degree preferred

Job description

Senior Manager, Quality Control Microbiology @ Advanced Therapy CDMO in Boston seeking calibration leader supporting the life sciences industry

Full-time, permanent role, onsite

We are seeking an experienced Senior Manager, Quality Control Microbiology to lead microbiological quality control operations supporting multiple programs, products, and GMP manufacturing activities. This role combines technical expertise with operational and people leadership, ensuring microbiological testing is performed accurately, efficiently, and in compliance with GMP regulations, approved procedures, and applicable regulatory requirements. You will oversee QC Microbiology activities across the product lifecycle, from development and technology transfer through clinical and commercial manufacturing. Working closely with Quality Assurance, Manufacturing, Analytical Development, Process Development, Validation, Engineering, Regulatory Affairs, and Project Management, you will play a key role in maintaining product quality, sterility assurance, and manufacturing readiness. The ideal candidate brings strong microbiology expertise, proven team leadership, and the ability to drive quality and operational excellence in a fast-paced, multi-program environment.

Job Duties

• Lead day-to-day QC Microbiology laboratory operations, overseeing microbiological testing of raw materials, in-process samples, finished products, stability samples, environmental monitoring, water systems, and manufacturing support activities.
• Manage laboratory priorities, staffing, workload, capacity, and turnaround times to meet manufacturing schedules, client commitments, and regulatory requirements while ensuring compliance with approved methods, specifications, and GMP procedures.
• Oversee environmental monitoring and utility monitoring programs, including EMPQ activities, quarterly trend reporting, water and clean utility testing, and support for aseptic process simulations (media fills).
• Lead and review investigations involving OOS/OOT results, deviations, laboratory errors, contamination events, environmental monitoring excursions, bioburden, and sterility concerns; drive root cause analysis, CAPA, change control, and risk assessments.
• Maintain GMP and regulatory compliance and inspection readiness, support client audits and regulatory inspections, ensure ALCOA+ data integrity standards, and lead, mentor, and develop QC Microbiology personnel.

Job Requirements

• 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 another GMP-regulated environment, including previous supervisory or management experience within QC Microbiology.
• Strong experience supporting clinical and/or commercial manufacturing, with expertise in environmental monitoring, microbiological testing, sterility assurance, utility monitoring, contamination control, and aseptic processing.
• Demonstrated experience leading OOS/OOT investigations, deviations, CAPAs, change controls, and microbiological method transfer, validation, verification, and implementation.
• Comprehensive knowledge of GMP microbiology laboratory operations, regulatory requirements, data integrity, and ALCOA+ principles, with experience supporting regulatory inspections and client audits; excellent technical writing, communication, analytical, and team leadership skills required.

Contact

You can reach out to Amit directly at [e-mail]