Manager, Quality Control

About the role

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.

Responsibilities

• 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 You Bring

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline.
• 7+ years of experience in a GMP-regulated analytical QC testing laboratory.
• 3+ years of progressive supervisory or management experience.
• Direct experience authoring, reviewing, and closing Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations.
• Demonstrated experience supporting, reviewing, or leading analytical method validation, verification, and transfer protocols within a regulated environment.
• Strong experience with Chromatography Data Systems (CDS), including data integrity, audit trail, and user access controls; hands-on administration experience preferred.
• Proven track record leading complex laboratory investigations, with advanced technical writing skills and proficiency in structured root-cause analysis methodologies to implement effective CAPAs and prevent recurrence.
• Experience applying Lean principles and tools to investigation workflows.
• Deep understanding of FDA/global regulatory guidance on handling OOS test results and data integrity principles (ALCOA+).
• In-depth knowledge of ICH, USP, and FDA guidelines regarding the validation, verification, and transfer of analytical procedures.
• Ability to apply Lean principles to the validation process—such as using standard templates, defining clear stage gates for method transfers, and reducing the cycle time from development to routine execution.
• Strong verbal and written communication skills with the ability to effectively collaborate across Quality, Analytical R&D, Manufacturing, Regulatory, and other cross-functional teams.
• Strong analytical, organizational, problem-solving, and project management skills with the ability to manage multiple priorities independently.

Nice to Have

• Master’s or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Advanced experience administering and maintaining Chromatography Data Systems, including audit trail review, user access, and data integrity controls.
• Experience with Lean laboratory transformation initiatives, including 5S, Visual Management, Value Stream Mapping, standard work, and waste reduction.
• Experience optimizing analytical methods to improve robustness, reduce testing time, and minimize solvent or reagent consumption.
• Experience evaluating internal versus external laboratory testing strategies and associated cost-benefit considerations.
• Experience supporting regulatory inspections and customer audits as a technical SME for analytical QC operations.
• Experience partnering with Analytical Research & Development and external laboratories on analytical method development, validation, verification, and transfer.