QA Lead, Quality Systems - Cell Therapy (GMP, Flexible PTO)

Cellipont Bioservices; The Woodlands (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) with strong employer match

Tuition reimbursement

Flexible work schedules

Employee referral bonuses

Job summary

Cellipont Bioservices is seeking a QA Lead for Quality Systems to enhance its Quality Management System (QMS) in The Woodlands, Texas. The role demands a strong candidate with over 8 years of experience in the biopharmaceutical or regulated pharmaceutical domain, ideally with a background in Quality Assurance.

The position offers robust benefits including career growth opportunities, 401(k) matching, and tuition reimbursement, all designed for unique health and wellness needs.

Qualifications

• Minimum of 8 years’ experience in the biopharmaceutical industry.
• At least 6 years in a Quality Assurance position focused on QMS.
• Strong background in GMP processes related to biological manufacturing.

Responsibilities

• Ensure compliance with Good Manufacturing Practices (GMP) for QMS.
• Lead audits and ensure actions for compliance are initiated.
• Support FDA and EMA regulatory inspections.

Skills

Quality Assurance

Good Manufacturing Practices (GMP)

Regulatory Compliance

Risk Management

Cross-Functional Collaboration

Education

BS in Life Sciences

Tools

Smartsheet

Excel

Job description

Cellipont Bioservices is seeking a QA Lead for Quality Systems to enhance its Quality Management System (QMS) in The Woodlands, Texas. The role demands a strong candidate with over 8 years of experience in the biopharmaceutical or regulated pharmaceutical domain, ideally with a background in Quality Assurance.

The position offers robust benefits including career growth opportunities, 401(k) matching, and tuition reimbursement, all designed for unique health and wellness needs.