QA Project Manager - Cell Therapy & Biologics (GMP)

Lonza; Houston (TX); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance, and disability (short/

Employee assistance programs

Paid time off (PTO)

Job summary

Lonza 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 regulated GMP setting. You will liaise with Manufacturing, Quality Control, Validation, Supply Chain, and leadership to ensure compliant, timely project delivery.

The role requires 5+ years in QA/QOps within GMP environments, strong cGMP knowledge, and proven client-facing capabilities.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Life Sciences, or a related scientific discipline.
• Minimum of 5 years of experience in Quality Assurance, Quality Operations, or a related GMP-regulated environment.
• Strong knowledge of cGMP regulations, quality systems, and compliance requirements within biotechnology, pharmaceuticals, Cell Therapy, or Gene Therapy.
• Experience managing customer-facing quality activities and building successful client relationships.
• Demonstrated project management experience leading multiple projects, timelines, and stakeholder groups simultaneously.
• Experience with quality systems including TrackWise, deviation management, investigations, CAPAs, change controls, and batch record review.
• Strong communication, presentation, negotiation, and stakeholder management skills.
• Ability to effectively manage complex customer interactions, resolve conflicts, and influence cross-functional teams.
• Experience working in Cell & Gene Therapy, Biologics, or CDMO environments preferred.
• Experience with TrackWise, SAP, and LIMS preferred.
• Project Management certification (PMP or equivalent) preferred.
• Strong analytical thinking, problem-solving abilities, and sound decision-making skills.
• Ability to thrive in a fast-paced environment while maintaining a high level of organization, accountability, and customer focus.

Responsibilities

• Lead Quality Assurance projects related to onboarding, technology transfer, and implementation of new Cell Therapy and Biologics clients.
• Manage project initiation, planning, execution, implementation, monitoring, and closeout activities while ensuring project objectives are achieved.
• Develop project scopes, timelines, deliverables, governance structures, success criteria, and communication plans.
• Serve as a primary client-facing quality representative, building strong customer relationships while ensuring compliance with Lonza quality standards.
• Coordinate cross-functional teams including QA, QC, Manufacturing, Validation, Supply Chain, and Technical Operations to support project execution.
• Lead project status meetings and communicate milestones, risks, deliverables, and progress updates to customers and senior leadership.
• Identify project risks, develop mitigation plans, and proactively resolve issues impacting timelines, quality, or customer satisfaction.
• Manage Quality Agreements with clients by establishing quality responsibilities, governance expectations, and compliance requirements.
• Support quality systems activities including deviation management, investigations, CAPAs, change controls, and batch record review.
• Generate and maintain project documentation, action logs, meeting minutes, and related quality records.
• Balance multiple projects, stakeholders, and competing priorities while ensuring successful delivery of commitments.
• Drive continuous improvement initiatives that strengthen quality systems, operational effectiveness, and customer experience.
• Ensure all activities are performed in accordance with cGMP regulations, regulatory requirements, and company procedures.

Skills

Quality Assurance

GMP compliance

Project management

Stakeholder management

Communication

Process improvement

Education

Bachelor’s degree in Biology, Chemistry, Life Sciences, or a related scientific discipline

Tools

TrackWise

SAP

LIMS

Job description

Lonza 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 regulated GMP setting. You will liaise with Manufacturing, Quality Control, Validation, Supply Chain, and leadership to ensure compliant, timely project delivery.

The role requires 5+ years in QA/QOps within GMP environments, strong cGMP knowledge, and proven client-facing capabilities.