Global (Quality) Data Integrity Lead

United States, Walkersville (Maryland)

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.

We are seeking an extraordinary Global (Quality) Data Integrity Lead to oversee the global remediation project and to act as  an  SME  regarding  Data  Integrity.  The  Global  Data  Integrity  Lead  monitors and communicates the status of site remediation efforts and is also involved in creating/updating corporate standards (CORP/GROUP) to clarify and address new regulations/regulatory trends.  The successful candidate will support management in strengthening the strategy at Lonza for Data Integrity and chairs routine DI Community of Practice meetings.

Key responsibilities:

  • Participation in the data integrity notification process and responsible for investigations, root cause analysis and CAPA remediation when problems arise as well as evaluation of sites for compliance with corporate and regulatory standards
  • Assist site personnel on DI cases and questions to ensure Lonza and regulatory requirements are implemented and participation in Data Governance Meetings
  • Mitigate the risk of regulatory findings / observations related to data integrity and foster a strong quality culture in the division related to Data Integrity
  • Escalate potential issues and report findings as well as oversee data integrity remediation to closure as well as actively participate in procedural revisions/clarifications as the division requires
  • Participation in Divisional Community of Practice Group to share approaches with similar sites with corporate/regulatory requirements

Key requirements:

  • Bachelor or Master Degree in Chemistry, Biotechnology, Life Science or related working experiences
  • Previous experience in Quality DI and GMP regulated pharmaceutical industry
  • Strong leadership experience as well as experience in management communication across complex global organizations
  • Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive

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: R43578
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