Manager, Quality Control

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Regular Full-Time Bedford, MA, Bedford, MA, US

3 days ago Requisition

Salary Range: $ To $ Annually

What You’ll Do

The Manager, Quality Control leads daily operations of the analytical 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 analytical chemistry, laboratory operations, data integrity, and a proven track record of applying Lean production methodologies to drive efficient, compliant, and right-first-time testing.

How You’ll Contribute

• 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 chemists 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).

What It Takes

This role has primary responsibility for the effective, compliant, and efficient operation of the analytical QC laboratory and the quality of analytical data supporting raw materials, in-process materials, and finished products. The position requires sound technical judgment and the ability to manage complex laboratory operations, investigations, analytical methods, and quality systems within a highly regulated GMP environment. Erroneous or delayed decisions may result in testing delays, product quality concerns, regulatory risk, or significant business impact.

Success in this role requires deep analytical chemistry expertise, strong knowledge of laboratory quality systems…