Quality Assurance Manager - Quality Control Support

United States, Houston (Texas)

Today Lonza is a global leader in life sciences. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity in the Quality Assurance group. The QA manager for QC Support will oversee the Quality Assurance team that supports the Quality Control team for Viral Vector laboratory, Cell Therapy laboratory and QC Raw Material team.  Ensures QA support for internal and external project and team meetings.  The QA manager will also perform as QA reviewer approver of master documents, executed documents and own or QA approve deviations and change controls in Trackwise system.  Candidate will also support internal and external audits as required. 

Key responsibilities:

  • Manages the Quality Assurance team that supports the Quality Control (QC) laboratories for Viral Vector, Cell Therapy ,and QC Raw Materials. 
  • Oversees all aspects of QA Support for QC operations within the facility, including but not limited to: material releases, SAP transactions, on the floor QA support,  executed document revision and approval (lab investigations, system suitability, stability protocols and reports, assay qualifications, etc.), deviation investigations, change controls, and master document revisions and approval (SOP, forms, material specifications, etc.).
  • Applies GMP knowledge to ensure that QC processes comply with effective procedures and regulatory requirements.
  • Ensures QA support for internal and external project and team meetings.  Interfaces with customers and internal groups for resolution of quality issues. Develops good working relationships with stakeholders and ensures appropriate and timely responses to client inquiries.  Informs QA Senior management of critical issues in a timely manner.
  • Builds and maintains expertise in the QA Support for QC team, including development of staff. 
  • Writes, revises, and/or approves quality, warehouse and sampling master documents (Ex. Standard Operating Procedures, forms, material specifications, etc.)
  • Reviews and approves executed documents (lab investigations, test records, stability protocols, logbooks, forms, material specifications, etc.).
  • Manages deviations and change controls as owner or QA approver in Trackwise system.

Key requirements:

  • Bachelor’s degree in life sciences required
  • QA/QC Leadership experience is required
  • GMP Commercial experience required
  • Quality Assurance Experience Required
  • Biotech & Commercial experience required
  • Experience with change control is required
  • Technical knowledge of QC processes – assay qualification, stability testing, lab investigations, sampling, testing, change control/deviations related to process
  • Prior experience with quality functions, aseptic techniques, GDP/GMP requirements, material release, investigation skills.
  • In-depth knowledge (Advanced) of cGMP principles.  Able to identify breach of cGMP principles and provide suggested corrective actions. 
  • Proficient in the use of spreadsheets, databases, and word processing software.
  • Prior experience with SAP, Trackwise and LIMS are a plus
  • Able to propose ideas during problem solving, root cause analysis, and process improvement events.   
  • Provides suggestions for improvement to documentation and workflows. 

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R44209