Head of Quality Assurance Ops – Cell Therapy
Location: This is an on-site position located in Pearland, TX
The purpose of this role is to oversee all aspects of quality assurance operations for the Lonza Houston cell therapy asset, ensuring that the quality systems and controls meet Lonza global standards and regulatory requirements.
What you will get:
A competitive compensation. 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:
Develops and implements the overall quality strategy for the facility.
Manages QA Ops budget and resources to maximize efficiency and
maintain quality/compliance at high levels.
Develops, directs, and maintains quality systems in support of CT manufacturing in a manner consistent with global quality systems, Lonza Corporate requirements and standards and current regulatory requirements, (primarily US FDA and European requirements) and others as needed.
Interfaces with site QA functions to support or develop appropriate
interfaces with the site-based QA systems.
Develop working relationships with other site functions for support of equipment, facility, utility, cleaning services and computer
validation/qualification.
Oversees all aspects of QA operations within the facility, including but not limited to executed batch record review, on the floor QA support, deviation investigations, change controls, Quality Agreements, and SOP and master batch record review.
For significant issues, interfaces with customers and internal groups for resolution of quality issues. Develops good working relationships with clients and ensures appropriate and timely responses to client inquiries.
Has decision-making authority for any Quality issues; informs Site Quality Head of critical issues in a timely manner.
Builds and maintains expertise in the QA Ops teams, including
development of staff.
Applies aseptic manufacturing experience, including aseptic process validation, to ensure that CT/GT operations meet customer and regulatory expectations and requirements for aseptic manufacturing at all phases of product development.
What we are looking for:
10+ years' experience Biopharmaceutical manufacturing experience and/or quality operations or quality systems working in a GMP environment.
5+ years' management of Quality Assurance staff.
5+ years' aseptic processing experience.
Experience with regulations (US, EU and other).
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 turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.