Senior/Lead Associate, Quality Assurance Operations

Job overview

The Senior/Lead Associate, Quality Assurance Operations role is onsite in Indianapolis, IN; compensation is not specified. The role supports Genezen’s Quality Assurance and Quality Systems team, which oversees operations connected to gene and cell therapy programs. The position provides technical quality oversight and day-to-day leadership for Quality Operations Associates. Through GMP compliance support, review of records and quality events, and collaboration across manufacturing, quality control, and other functions, it helps protect product quality and maintain regulatory readiness.

What you'll do

• Provide technical guidance, coaching, and training to Quality Operations Associates
• prioritize QA floor support
• review junior associates’ work
• mentor investigations, CAPAs, change controls, and root-cause analysis
• lead continuous improvement and complex investigations
• oversee manufacturing and QC compliance
• review batch records and controlled documents
• support product disposition, audits, and inspections
• coordinate with cross-functional teams.

What we're looking for

Skills & competencies

quality assurance

qa operations

senior associate

gmp compliance

indianapolis in

genezen

quality systems

capa

change control

deviation investigations

batch records

gene therapy

Work arrangement

• Weekend coverage required

Benefits & perks

• Paid vacation and sick time
• observed and floating holidays
• volunteer day
• 401(k) match up to 6% of salary
• Share Appreciation Rights
• healthcare plans
• FSA and HSA
• dental, vision, life, disability, and AD&D coverage.

Why this role

Requires a bachelor’s degree in science or a related field and 6–8+ years of pharmaceutical or biologics quality assurance experience; schedule may change with business needs.

About the employer

Genezen is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.