QC Project Lead: Tech Transfer & Compliance

Lonza Group Ltd.; Houston (TX); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability保险

Employee assistance programs

Paid time off

Job summary

Lonza Group Ltd. is seeking a Quality Control Project Lead in Pearland, TX for on-site work. The role focuses on introducing new methods, supporting investigations, and acting as the QC representative on project teams to ensure regulatory compliance and successful QC testing for cell and gene therapy products.

The position requires 3–5 years in QC, a bachelor’s degree in a scientific field, and strong communication skills for cross-functional collaboration with QA, MSAT, and manufacturing.

Qualifications

• 3–5 years of experience in Quality Control.
• Strong understanding of cGMP principles and regulatory compliance.
• Experience with method validation/qualification and technology transfer in a QC environment.

Responsibilities

• Lead tech transfer activities including development of transfer plans, protocols, and reports.
• Provide QC representation in project team meetings and communicate project status and timelines.
• Review regulatory guidance and internal policies to ensure compliance with cGMP standards.
• Write, review, and approve test records, sampling plans, specifications, and QC documentation.
• Support stability programs and track testing progress and deliverables.
• Collaborate with cross-functional teams including QA, MSAT, and manufacturing.
• Assist with deviations, OOS investigations, CAPAs, and audit responses.

Skills

Quality Control

Project leadership

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in a scientific discipline

Job description

Lonza Group Ltd. is seeking a Quality Control Project Lead in Pearland, TX for on-site work. The role focuses on introducing new methods, supporting investigations, and acting as the QC representative on project teams to ensure regulatory compliance and successful QC testing for cell and gene therapy products.

The position requires 3–5 years in QC, a bachelor’s degree in a scientific field, and strong communication skills for cross-functional collaboration with QA, MSAT, and manufacturing.