Data Integrity Officer

United States, Hayward (California)

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 Data Integrity Officer (DIO) is a Subject Matter Experts (SME) for data integrity requirements and expectations. The DIO is responsible for management and oversight of data integrity issues in clinical and commercial GMP operations, including identification and investigation of suspect data integrity events managed thru the existing QMS processes. The DIO serves as a key member of the GMP Data Governance Program to ensure that data integrity regulations and expectations are effectively incorporated into site GMP Operations and decisions. The individual will be responsible to develop and oversee execution of the Strategic Data Integrity Plan and relevant annual Plans, in partnership with IT, QC, QA and other stakeholders including Lonza Corporate and key customers as appropriate. 

Key responsibilities:

  • Monitor worldwide regulatory requirements and expectations for data integrity.  Initial focus will be on the US and EU requirements.  This includes both new requirement or changes in existing regulations, guidelines, guidance, and inspection and enforcement trends.
  • Inform senior management of potential areas of risk
  • Lead gap assessment effort for new and existing regulations and guidance, identify gaps requiring remediation and propose plan to the Data Governance Committee for approval and execution (assuming this would be part of their responsibilities, if not identify the approving organization)
  • Establish and implement the structure, membership, responsibilities, and activities of the GMP Data Governance Committee (DGC) including identification of an executive sponsor.
  • Develop the overall Strategic GMP Data Integrity Plan based on a vision of the ‘desired state’.
  • Lead prioritization of corrective actions and establish timelines for resolution and responsibilities (CAPAs).
  • Review the effectiveness of the data governance systems to ensure data integrity and traceability Identify improvement activities
  • Develop the Data Integrity Plan including prioritized activities, responsibilities and timelines for activity completion.
  • Ensure the procedures and practices are put in place to ensure that vendors and suppliers have an adequate data governance process in place.
  • Maintain inventory of all policies and procedures that support data integrity.

Key Requirements:

  • Manufacturing – Pharmaceutical or Medical Device – Advanced Experience
  • BS degree -        Field of Study - Science, IT, Business or Engineering
  • Excellent written and verbal communication skills.
  • Embraces a culture of sharing knowledge and training others.
  • Strong ability to lead cross-functional teams
  • Solid understanding of inter-department maintenance operations.
  • Proficient at driving methods of change in achieving productivity improvement goals
  • Mature business acumen demonstrated by understanding the role maintenance plays in Lonza’s asset management business model
  • Solid knowledge of CMMS systems, preferably SAP Plant Maintenance module.  Proficiency in Microsoft Office Suite applications, exposure to cGMP guiding work practices and principles

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: R25895