Quality Assurance Supervisor - Cell Therapy Operations (2nd Shift)

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.

Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing.  We are looking for professionals to grow with us and we have an exciting opportunity in our Quality Assurance(QA) group for a QA Supervisor Cell Therapy Operations (2nd Shift). The QA Supervisor is responsible for ensuring cGMP compliance during the production, testing, release, and distribution of cell therapy product. Responsible for supporting customer inspections, representing the Cell Therapy QA team. Manages a team responsible for providing QA support on project teams, acting as client interface and otherwise ensuring that quality requirements are met. Manages the oversight of batch record and APV development, deviations, OOS, CAPAs, technical investigations and batch release related to cell therapy products.

Key responsibilities:

  • Manage the Cell Therapy QA team. Develops and plans departmental goals, establishes timelines, and monitors progress and completion.
  • Develop and approve cGMP documents including, but not limited to, SOPs, batch records, and specifications.
  • Auditing of both internal departments and suppliers as necessary.
  • Managing Cell Therapy complaint handling and ensuring that quality related complaints are investigated and resolved.
  • Supports client audits as Cell Therapy QA subject matter expert.
  • Ensure deviations, investigations and recalls are completed.
  • 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.
  • Manages the evaluation of batch records and corresponding component and test records to ensure completeness.
  • Evaluate requirements for starting materials, packaging materials, bulk, and final products.
  • Ensures that the required initial and continuing training of QA personnel is completed and adapted according to need.
  • Acts as a resource to other departments regarding the implementation of Quality

Key requirements:

  • Bachelors’ degree in a related field and relevant experience in the biotech/pharmaceutical industry with proven management experience.
  • Must be able to direct and organize a multifaceted organization in compliance with cGMP.
  • Must be able to interpret, understand, and apply regulatory requirements related to cGMP activities.
  • Must have knowledge of cGMP requirements and experience in the application of such principles during development.
  • Must have an understanding of regulatory, compliance, and validation issues, as well as experience in writing and reviewing the associated technical documents, SOPs, and protocols.
  • Must have strong management and interpersonal skills with the ability to build a successful team.
  • Demonstrates skills in problem solving and providing solutions.
  • Self-motivated, works well independently and as a team player.
  • Able to initiate and lead cross functional teams.
  • Able to clearly communicate problems and observations with management from other departments.
  • Interacts effectively with staff members from multiple levels and departments.
  • Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
  • Must be able to work 2nd shift hours of 3:00 PM - 12:00 AM

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: R45070