Quality Assurance Lead, Quality Systems (Cell Therapy)

Job overview

The Quality Assurance Lead, Quality Systems (Cell Therapy) role is onsite in Spring, TX; compensation is not specified. Cellipont Bioservices says its work aims to bridge clients’ discoveries to patient cures. This position leads key aspects of the Quality Management System and supports GMP compliance. The role helps maintain compliant quality processes across the site by overseeing quality-system activities, reviewing and approving records, conducting audits, supporting inspections, and guiding personnel on requirements. It contributes to reliable regulated operations and continuous improvement through risk-based quality oversight, training, and corrective and preventive actions.

What you'll do

• Serve as a key contact for deviations, CAPAs, effectiveness checks, and change controls
• participate in the Change Control Review Board
• review or approve quality records
• generate compliance metrics
• perform internal audits and participate in or lead client audits
• support regulatory inspections and supplier qualification audits
• identify quality issues and propose risk-based solutions
• participate in or lead quality and process improvement initiatives
• guide personnel on GMP compliance
• train staff on quality processes
• generate or revise GMP documents
• support investigations and root-cause analysis
• interpret applicable GMP and regulatory guidance.

What we're looking for

Skills & competencies

quality assurance lead

quality systems

cell therapy

quality management system

gmp compliance

deviations

capa

change control

internal audits

supplier quality

spring tx

cellipont bioservices

Work arrangement

• Weekend coverage required

Benefits & perks

• Career growth opportunities, defined career path and annual performance review, cross-functional exposure, health and wellness benefits, 401(k) employer match, tuition reimbursement, employee referral bonuses, flexible work schedules, PTO, and paid holidays.

Why this role

The role requires a life sciences bachelor’s degree, at least eight years in the biopharmaceutical or regulated pharmaceutical industry, and at least six years in Quality Assurance focused on QMS. Cell therapy experience is preferred.

About the employer

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