Manager, Quality Control

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Quality Assurance & Validation Regular Full-Time Bedford, MA, Bedford, MA, US

30+ days ago Requisition

Salary Range: $ To $ Annually

The Senior Manager, Quality Control leads daily operations of the Quality Control testing laboratory, ensuring raw materials, in-process samples, and finished products meet established quality and regulatory requirements. In this role, you serve as a hands-on technical leader with deep technical expertise in quality control, laboratory operations, data integrity, and a proven track record of applying Lean production methodologies to drive efficient, compliant, and right-first-time testing.

• Manage daily laboratory operations and workflows applying Lean Laboratory principles, including 5S, Visual Management, and Value Stream Mapping, to maximize efficiency and minimize testing lead times.
• Establish, monitor, and improve laboratory KPIs, including Right-First-Time (RFT), Sample Turnaround Time (TAT), and Overall Equipment Effectiveness (OEE).
• Lead continuous improvement initiatives to eliminate non-value-added activities, reduce waste, improve laboratory throughput, and eliminate testing bottlenecks.
• Serves as the subject matter expert (SME) for the laboratory’s Chromatography Data System (CDS), ensuring data integrity, compliant audit trails, appropriate user access controls, and effective system administration.
• Provide technical oversight of analytical instrumentation, including UV-Vis spectrophotometers, rheometers, automated titrators such as Karl Fischer and potentiometric titrators, FT-IR spectrometers, and Total Organic Carbon (TOC) analyzers.
• Oversee the troubleshooting, qualification, calibration, and maintenance of analytical laboratory instrumentation to ensure reliable and compliant testing.
• Review and approve complex analytical data and laboratory results in accordance with applicable regulatory and quality requirements.
• Lead investigations into Out-of-Specification (OOS), Out-of-Trend (OOT), and anomalous laboratory results using structured root-cause analysis (Fishbone, 5 Whys).
• Author, review, and approve standard operating procedures (SOPs), test methods, and validation protocols.
• Manage lab deviations, CAPAs (Corrective and Preventive Actions), and change controls effectively.
• Serve as a primary host and technical escort during internal, client, and regulatory agency audits.
• Supervise, mentor, and evaluate a team of QC analysts and technicians.
• Cross-train personnel on various instruments to ensure workforce flexibility aligned with Lean demand-leveling.
• Manage laboratory chemical inventory and service contracts for analytical instruments.
• Support analytical method development, validation, verification, and transfer protocols for new and existing products and methods across all core instruments.
• Author, review, and approve validation/transfer protocols and final reports in accordance with ICH Q2 and USP guidelines.
• Partner with Analytical Research & Development and external labs to ensure a Lean, structured, and right-first-time method transfer into the routine testing lab.
• Evaluate cost benefit of internal vs external lab testing.
• Evaluate existing analytical methods for optimization, updating procedures to improve robustness, reduce runtime, and minimize solvent/reagent waste (Green Chemistry/Lean alignment).

This role has primary responsibility for the effective, compliant, and efficient operation of the QC laboratory and the quality of testing data supporting raw materials, in-process materials, and finished products. The…