Head of QA Operations - Cell Therapy

Lonza•Houston, TX

5d•Onsite

About The Position

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.

Requirements

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).

Responsibilities

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.