Senior QA Lead – Viral Vector & Cell Therapy

Lonza Biologics, Inc.; Houston (TX); On-site; Confidential; Full time

Benefits offered by this job

Performance bonus

Health insurance

Dental insurance

Vision insurance

401(k) matching

Life insurance

Disability insurance

Employee assistance programs

Paid time off

Job summary

Lonza Biologics, Inc. in Houston, TX is seeking a senior Quality Assurance Specialist III - Viral Vector. The role ensures QA oversight across viral vector and cell therapy manufacturing, maintains cGMP compliance, and leads complex quality investigations.

You will mentor QA staff and support continuous improvement in a fast-paced biopharma environment. The position requires strong GMP experience, batch record review, and collaboration with manufacturing, QC, and engineering teams.

Qualifications

• Associate’s or Bachelor’s degree in Life Sciences, Engineering, or related field; relevant experience may substitute.
• Experience in GMP-regulated biopharma manufacturing including viral vectors.
• Strong attention to detail reviewing GMP docs and quality records.

Responsibilities

• Provide quality oversight for viral vector and cell therapy manufacturing, ensuring cGMP and quality system compliance.
• Support manufacturing floor activities with QA presence and real-time decision making.
• Review and approve Master Batch Records, GMP documents, and production records.
• Lead investigations, deviations, CAPAs, and change controls.
• Provide informal leadership and mentorship within the QA team.
• Maintain inspection readiness and support regulatory alignment.
• Perform cleanroom activities with gowning and quality oversight.
• Collaborate across Manufacturing, QC, Engineering, and facilities.

Skills

QA leadership

cGMP

GMP documentation

QA experience

Biologics manufacturing

Viral vector knowledge

Investigations

CAPA management

Change controls

Documentation review

Education

Associate/Bachelor’s degree in Life Sciences or related field

Tools

LIMS

Electronic batch records

Job description

Lonza Biologics, Inc. in Houston, TX is seeking a senior Quality Assurance Specialist III - Viral Vector. The role ensures QA oversight across viral vector and cell therapy manufacturing, maintains cGMP compliance, and leads complex quality investigations.

You will mentor QA staff and support continuous improvement in a fast-paced biopharma environment. The position requires strong GMP experience, batch record review, and collaboration with manufacturing, QC, and engineering teams.