Associate Director, Quality Control Strategy and Operations

United States, Houston (Texas)

Today, Lonza is a global leader in life sciences operating across three continents. 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 Associate Director, QC Strategy and Operations will support the Site QC Head in driving, together with the respective QC functions, the daily execution of QC Operations in all areas according to the 6S and LEAN lab principles to assure a seamless Supply Chain of the site. This person will assure QC Operations in line with Quality policies and procedures to ensure compliance with cGxP standards, corporate policies, US FDA, and other regulatory requirements as applicable. Support others in driving superior standards for QC Improvement Projects. Support the QC strategy with a proactive development of the Laboratory Operations, in line with infrastructure and Capex needs, in line with the strategic Site Expansion. Partner very closely with the assets, site functional leads, the Manufacturing Operations teams and other teams that support or collaborate with QC operations.

Key responsibilities:

  • Develop, facilitate,  and Manage an effective and efficient meeting organization in the site QC Organization incl. tracking of actions and their closure
  • Drive daily QC Operations on shop floor level to assure QC results availability for On Time Batch Approval and On Time Incoming Inspection Accuracy to support On Time in Full Supply Chain of all products in scope.
  • Drive timely closure of Quality incidents in Quality Control. Assure Quality Operations in line with Lonza Group Procedures/Corporate requirements and standards and current regulatory requirements (primarily US FDA and European requirements) related to Quality Control and others as applicable. Help to ensure inspection readiness at any time.
  • Facilitate and manage strategic and operational meetings and the respective QC governance on site level. Oversee the consolidated QC reporting on behalf of the site and assets and according to global system requirements
  • Identifies and lead the implementation of QC improvement projects that impact both the Cell Therapy and Viral Vector assets, and also other functions as applicable (Inbound testing, qualification, validation) in a manner consistent with global and local improvement projects. Drive cross-functional collaboration on QC Strategic projects for Assets and aligned with Site Business Strategy.
  • Manage any Staff projects on behalf of the Quality Control Head
  • Support the implementation of the overall QC strategy for the facility expansion projects.  Partner with the Leadership Team and acts as the lead Quality Control SME within the facility expansion projects. 
  • Works across the function to improve the QC customer interaction models to improve the overall customer experience.

Key requirements:

  • Bachelors degree in life science field or related engineering field. Masters degree preferred
  • Experienced knowledge in biopharmaceutical manufacturing experience and/or quality operations or quality systems working in a GMP environment
  • Additional background in business administration and Lean management is a plus
  • Intermediate knowledge of management of Quality Assurance staff and aseptic processing
  • Display ability to incorporate rapid changes in priorities into the QA Ops projects or schedule of activities 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
  • Display a clear willingness to listen to others.  Has good interpersonal skills and can collaborate interdepartmentally in an effective manner to achieve objectives
  • Effectively presents information and ideas verbally and in writing to clients and others in a manner that facilitates understanding.  Drives to meet timelines for client requests
  • Show commitment and dedication and strives to be ahead of schedule.
  • Acts proactively to identify gaps or issues, leads effort to implement improvements and provides guidance to create a more streamlined workflow
  • Display a willingness to make decisions for the group and to interface with other department leadership to address areas of conflict or misunderstanding.  Takes the lead in escalating compliance concerns and actively pursues resolution for those concerns
  • Practices safety awareness at all times and considers impact of actions prior to executing activities

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: R39206