QA Project Manager - Cell Therapy & Biologics (Onsite Houston)

Lonza Group Ltd.; Houston (TX); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance, disability insurance

Employee assistance programs

Paid time off (PTO)

Job summary

Lonza Group Ltd. in Houston, TX seeks a Quality Assurance Project Manager to lead QA projects supporting onboarding, technology transfer, and implementation for Cell Therapy and Biologics clients in a GMP manufacturing setting.

You will partner with Manufacturing, Quality Control, Validation, Supply Chain, and Technical Operations to drive project success while ensuring compliance with Lonza quality standards and regulatory requirements.

Qualifications

• Bachelor’s degree is required in a life sciences field and 5+ years in QA/Q Operations in GMP settings.
• Experience leading customer-facing quality activities and coordinating cross-functional teams.
• Strong knowledge of cGMP, quality systems, and biopharma/CDMO environments.

Responsibilities

• Lead QA projects related to onboarding, technology transfer, and implementation for Cell Therapy and Biologics clients.
• Manage initiation, planning, execution, monitoring, and closeout of projects with clear objectives.
• Develop scopes, timelines, deliverables, governance, success criteria, and communication plans.
• Serve as primary client-facing quality representative and maintain Lonza standards.
• Coordinate QA, QC, Manufacturing, Validation, Supply Chain, and Technical Operations teams.
• Lead status meetings and report milestones, risks, and progress to clients and leadership.
• Identify risks, develop mitigation plans, and resolve issues affecting timeline/quality.
• Manage Quality Agreements with clients and define responsibilities and governance.
• Support quality systems activities including deviations, investigations, CAPAs, change controls, and batch review.
• Generate and maintain project docs, logs, and quality records.
• Balance multiple projects and priorities to ensure on-time delivery.
• Drive continuous improvement to strengthen quality systems and customer experience.
• Ensure activities comply with cGMP, regulatory requirements, and Lonza procedures.

Skills

Quality Assurance

Project Management

cGMP regulations

Client-facing

Cross-functional leadership

Communication

Risk management

Document control

Education

Bachelor’s degree in Biology, Chemistry, Life Sciences, or related field

Tools

TrackWise

SAP

LIMS

Job description

Lonza Group Ltd. in Houston, TX seeks a Quality Assurance Project Manager to lead QA projects supporting onboarding, technology transfer, and implementation for Cell Therapy and Biologics clients in a GMP manufacturing setting.

You will partner with Manufacturing, Quality Control, Validation, Supply Chain, and Technical Operations to drive project success while ensuring compliance with Lonza quality standards and regulatory requirements.