QA Compliance Team Lead

United States, Tampa (Florida)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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’s Tampa, FL location is searching for an experienced QA Compliance Team Lead to join our stellar Quality Assurance team. As our QA Compliance Team Lead, you will be assisting and supporting the organization with monitoring of compliance quality processes and standards for a GMP contract development / manufacturing organization (CDMO).  Additionally, you will conduct internal production/process, manufacturing, packaging and quality control audits and risk assessments. To be successful in this role, you must have experience in commercial pharmaceuticals, biologics, and/or medical device industry.

Key responsibilities: 

  • Assist management and execution of Quality Systems, i.e. Deviations, CAPA, Change Controls.
  • Provide guidance to back room during regulatory audits.  Lead internal and external audits, track audit and inspection commitments.  Independently hosts customer audits along with support team. 
  • Independently write / approve SOPs, Master Batch Records, customer audit and regulatory CAPA.
  • Lead investigations including Root Cause Analysis, CAPA and impact to product safety, identity, strength, quality or purity. 
  • Assist in completion of regulatory tasks including maintaining internal licenses and certificates, client requests. 

Key requirements: 

  • Bachelor Degree in Science or Engineering related field.
  • Substantial QA experience within the pharmaceutical/biotech industry is required.
  • Prior mentorship experience (this is not a manager role).
  • Excellent communication skills (written and oral) with ability to influence people and outcomes.
  • Self starter with ability to work in a deadline driven environment.

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: R28237