Quality Assurance Project Manager

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

Shift: Standard Business Hours with flexibility to support client and business needs

As a Quality Assurance Project Manager, you will lead and manage Quality Assurance projects supporting the onboarding, technology transfer, and implementation of Cell Therapy and Biologics clients within a highly regulated GMP manufacturing environment. This role serves as a key liaison between clients and cross-functional teams, ensuring projects are executed successfully while maintaining compliance with cGMP regulations, quality systems, and Lonza standards. You will partner closely with Manufacturing, Quality Control, Validation, Supply Chain, Technical Operations, and senior leadership to drive project success and deliver exceptional customer experiences.

What you will get:

A competitive compensation package. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus
• Medical, dental and vision insurance
• 401(k) matching plan
• Life insurance, as well as short-term and long-term disability insurance
• Employee assistance programs
• Paid time off (PTO)

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• 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.

What we are looking for:

• 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.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.

If you're ready to help drive quality excellence, build strong client partnerships, and support the delivery of life-changing Cell & Gene Therapy products, we look forward to welcoming you on board.

Reference: R80577

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.