Director / Senior Director, Quality Assurance Operations

Job overview

The Director / Senior Director, Quality Assurance Operations is an onsite, full-time role in Lexington, MA, with an annual salary range of $170,000–$240,000. Genezen develops processes, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials. The director oversees the Quality Management System and quality assurance across GMP operations, ensuring alignment with global cGMP requirements. The role leads investigations, audits, inspection readiness, quality metrics, and the QA organization to support compliant operations and the delivery of gene therapy medicines.

What you'll do

• Develop, implement, maintain, and improve Quality Management Systems
• guide operations on phase-appropriate cGMP requirements
• manage investigations and CAPA
• review and disposition materials and products
• provide QA support to manufacturing, MSAT, facilities, engineering, validation, quality control, and supply chain
• develop quality metrics and report trends and risks
• support internal and external audits
• host and support health authority inspections
• assess regulatory changes
• build and maintain a high-performing QA organization
• manage client quality relationships.

What we're looking for

Skills & competencies

full-time

quality assurance director

quality assurance operations

lexington ma

genezen

gene therapy

gmp

quality management system

capa

fda inspections

$170k–$240k

Work arrangement

• Weekend coverage required

Benefits & perks

• Paid vacation and sick time
• observed and floating holidays
• volunteer day
• 401(k) match up to 6%
• share appreciation rights
• healthcare plans
• FSA and HSA
• dental and vision
• employer-paid basic life and personal accident insurance
• voluntary disability and other insurance.

Why this role

The posting seeks 10+ years of relevant GMP experience in pharma or biotech in a quality role; work schedule may change based on business needs.

About the employer

Genezen is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.