Manager, Quality Assurance
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
The Quality Assurance Manager is responsible for ensuring Clean Good Manufacturing Practices (cGMP) compliance during the commercial production, testing, release and distribution of viral vector products. Responsible for the supporting regulatory or customer inspections, representing the Quality Assurance Department. Manages the oversight of batch record, deviations, out of specification (OOS), corrective and preventive actions (CAPAs), technical investigations and batch release related to batch viral products.
- Manage the Quality Assurance viral vector Operation Teams. Develops and plans departmental goals, establishes timelines and monitors progress and completion. Oversees commercial batch release.
- Provides oversight of aseptic operations, including supporting Quality Assurance (QA) on the floor team to observe aseptic processing, including media fills to meet US and international aseptic processing requirements. Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes.
- Provides direction for deviations and complaint investigations; Managing deviations, CAPAs and Complaint handling and ensuring that quality related deviations, complaints are escalated, investigated and resolved.
- Develops and approves cGMP documents including, but not limited to, Standard Operating Procedures (SOPs), batch records and specifications. Ensures process is efficient.
- Supports regulatory or client audits as subject matter expert.
- Bachelor’s Degree in Life Sciences, Engineering or related field
- Extensive GMP experience in commercial biologics manufacturing or equivalent
- Extensive experience in the Management of Quality Assurance Staff
- Experience with regulations – Unites States and European Union (US, EU and other)They changed their mind
- Experience in an aseptic manufacturing environment
- Working knowledge and experience in aseptic manufacturing regulations is preferred.
- Display ability to incorporate rapid changes in priorities into the commercial activities or projects and to communicate those changes in a positive way to the staff.
- Ability to support efforts in other functional areas when needed and assume additional responsibilities at times to support a project or sudden transitions of personnel.
- Ability to suggest new ideas for improvements or to make recommendations for an identified compliance concern.
- Ability to communicate status, needs, forecasts, risks and timelines effectively to management. Deliver data as appropriate demand planning or staffing planning.
- Effectively presents information and ideas verbally and in writing to stakeholders and others in a manner that facilitates understanding. Responds to stakeholders requests in an effective and professional manner.
- Requires collaboration with cross functional team members, must be able to balance normal stress to meet deadlines for various site projects
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.