Director, Head of Quality SM, Tampa

United States, Tampa (Florida)

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 Director, Head of Quality Small Molecules is responsible to lead and coordinate all activities related to the Site Quality Unit (quality systems, quality assurance and quality control) and ensure there are appropriate resources available to meet production demands in our Tampa, Florida Solid Oral Dose facility. The current team has 2 direct reports and approx. 45 indirect reports.

Key Accountabilities:

  • Lead Quality team responsible for following functions: Quality Assurance, Final Batch Release and Incoming Inspection, Documentation Control, Validation and Production Line Clearance, Continuous improvement on site, Quality Control, Stability programs.

  • Assure cGMP and compliance.

  • Approval of major and critical deviations.

  • Approval of new product introduction.

  • Approval of CAPA plans following customer audits and HA inspections.

  • Approval and evaluation of the Annual Quality Review.

  • Responsible for Data Integrity for Production and QC Equipment (data recording).

  • Responsible to keep Site Master File updated and inform authorities of relevant changes.

  • Management of GMP inspections

  • Embeds Quality Culture at site.

  • Issuing/updating the Quality Policy, in cooperation with leadership team.

  • Issuing/updating the Quality Policy, in cooperation with leadership team.

  • Manage Quality Budget within the site across QA and QC.

  • Develop People within quality and at Site.

  • Member of Site Leadership Team and Global Quality Leadership Team for Small Molecules

  • Comply with EHS policies and guidelines. Ensure appropriate housekeeping of Quality area, especially QC.

  • Drives for results with a high quality of performance and accountability.

Key Requirements:

  • Bachelor of Science or Higher Education in Chemistry, BioChemistry or Pharmacy.

  • 10+ years in Quality of Manufacturing Operations in a cGMP regulated environment

  • 5 - 10 years of managing personnel.

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: R54876