Data Integrity Lead (m/f/d)

Switzerland, Basel

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.

For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the Data integrity Lead position

Key responsibilities:

  • Drives forward global initiatives which are rolled out across all Lonza sites

  • Author of GMP documents providing the data integrity framework for the Basel site

  • Implement and lead a DI forum to assure alignment across the different Lonza DPS Basel groups working under GMP and ISO standard

  • Supports site management to strengthen data integrity processes

  • Lead the site data integrity program and connect with other sites to assure an aligned approach

  • Reduce risk of regulatory findings/observations related to data integrity (e.g. by screening industrial trends / HA guidance or published inspection reports)

  • Support the QA compliance team in HA inspections or customer Audits

  • Compile data integrity trainings and set the standard for proper qualification of scientists, team leaders and the Lonza DPS Basel site lead team

Key requirements:

  • Academic degree in Engineering, Pharmaceutical Technology, natural science or related field (Master or higher)

  • Significant working experience in pharmaceutical industries and GMP controlled environment preferable in Quality Control, Production or Quality Assurance

  • Extended experience from participation in audits and authorities' inspections

  • Very  good  working  knowledge  in  EU  and  US  GMP  regulations  relevant  to  good documentation practice and data integrity

  • Experiences to work in a matrix organization

  • Excellent knowledge of written and spoken English

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.

Reference: R51133