Manager, Quality Control

Anika Therapeutics•Bedford, MA

6d•$122,000 - $152,000•Onsite

About The Position

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.

Requirements

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 Haves

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.

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.
Serve 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).