Senior QC Lab Lead — Lean, GMP & Data Integrity

Anika Therapeutics, Inc.; Bedford (MA); On-site; USD 135,000 - 165,000; Full time

Benefits offered by this job

Discretionary bonus program

Healthcare benefits

401(k) plan with company match

Employee stock purchase plan

PTO and holidays

Job summary

Anika Therapeutics, Inc. in Bedford, MA is seeking a Senior Manager of Quality Control to lead the QC laboratory’s daily operations and ensure compliance with GMP and regulatory requirements.

You will drive Lean improvements, oversee analytical instrumentation, and mentor a team of QC analysts to deliver right-first-time testing and robust data integrity across raw materials, in-process, and finished products.

Qualifications

• Hands-on leadership of QC lab operations and data integrity.
• Experience driving Lean improvements in laboratory settings.
• Proven record of investigating OOS/OOT and data anomalies.

Responsibilities

• Manage daily QC lab operations and workflows with Lean principles.
• Lead investigations and CAPAs for laboratory deviations.
• Author and approve SOPs, test methods, and validation protocols.
• Support method development, validation, transfer, and regulatory readiness.

Skills

Quality Control

Lean principles

GMP

Data integrity

OOS investigations

CAPA

Method transfer

Cross-functional leadership

Analytical method validation

Regulatory compliance

Education

Bachelor’s degree in Chemistry

Experience in GMP QC lab

Tools

Chromatography Data System (CDS)

UV-Vis spectrophotometers

Rheometers

Titrators (Karl Fischer, potentiometric)

FT-IR spectrometers

TOC analyzers

Job description

Anika Therapeutics, Inc. in Bedford, MA is seeking a Senior Manager of Quality Control to lead the QC laboratory’s daily operations and ensure compliance with GMP and regulatory requirements.

You will drive Lean improvements, oversee analytical instrumentation, and mentor a team of QC analysts to deliver right-first-time testing and robust data integrity across raw materials, in-process, and finished products.