Associate Director, Quality 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, Quality Strategy & Operations will lead the Quality strategy for site expansion and process improvement projects with the objective to drive a forward looking organizational development of the Quality Unit (Quality Assurance, Quality Operations and Quality Control), a proactive development of the Quality System, an effective execution of customer interactions and simplification of processes.

This person will drive superior standards for quality improvement projects, manage in collaboration with the QLT and the assets the quality improvement project portfolio at site originating from the risk register and as outlined in the business unit and Site Quality Plan.

This person will develop and manage an effective and efficient meeting organization in Quality including tracking of actions and their closure. Facilitate key Operational Excellence integrated programs such as Critical Chain, Program reviews and Management of the daily meetings.

The Associate Director will partner closely with the assets and functions at site and support the Quality Leadership team in daily execution. Act as a strong partner to the Manufacturing Operations teams (Viral Vector & Cell Therapy) and other teams that support operations (e.g. Quality Control, Materials Management, Engineering, Validation and Quality Systems).

Key responsibilities:

  • Implements the overall quality strategy for the facility expansion projects.  Partners with the Site Director, Head of Quality and Senior Leadership Team to ensure alignment with Manufacturing and support functions in executing the strategy.  Acts as the lead Quality SME for significant quality or compliance issues within the facility expansion projects. 
  • Identifies and lead the implementation of QA improvement projects that impact both the Cell Therapy and Viral Vector assets 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. 
  • Works across the quality function to improve the Quality Operations/Quality Control customer interaction models to improve the overall customer experience.
  • Oversee the consolidated Quality reporting on behalf of the site and assets and according to global system requirements
  • Drive cross-functional collaboration on Quality Strategic projects for Assets and aligned with Site Business Strategy.
  • Drive financial excellence in Quality
  • Supervise timely escalations on behalf of the site in line with Lonza Group Procedures
  • Manage any Staff projects on behalf of the Site QA Head

Key requirements:

  • Intermediate knowledge of aseptic processing and management of Quality Assurance Staff
  • Experienced knowledge of 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.
  • 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: R38771