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 Lead is a Subject Matter Expert (SME) for data integrity requirements and expectations from the Lonza Quality Management System and relevant Health Authorities. The Data Integrity Lead is responsible for management and oversight of data integrity issues in clinical GMP Drug Substance facility and supports the identification and remediation of data integrity issues. This person will serve 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 and management of annual Data Integrity Plans, in partnership with key partners in Engineering, Manufacturing, QC, and QA.
Key responsibilities:
Lead and manage the site’s DI improvements to ensure compliance with worldwide regulatory requirements and expectations for data integrity. Focus is on the US and EU requirements. This includes both new requirement or changes in existing regulations, guidelines, and inspection and enforcement trends.
Assess requirements and communicate to potentially impacted areas including Data Governance Committee
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)
Ensure incorporation of new requirement(s) into the Quality System
Communicate information and inspection enforcement trends to Data Governance Committee for possible actions
Ensure incorporation of new expectations identified in inspection and enforcement actions are into the Quality System as appropriate.
Lead the Governance Committee for Data Integrity and manage its structure, membership, responsibilities, and activities to support site implementation and global initiatives.
Act as the site DI representative on the Global Governance Committee for Data Integrity.
Maintain annual Hayward Data Integrity Plans based on a vision of the ‘desired state’ and input from the Global Data Integrity Plan.
Ensure gaps are identified
Lead prioritization of corrective actions and establish timelines for resolution and responsibilities (CAPAs).
Track progress and completion of associated CAPAs
Review the effectiveness of the data governance systems to ensure data integrity and traceability Identify improvement activities
Act as a resource for change owners and system owners from project definition to GMP release to ensure appropriate management through system lifecycle.
Ensure that effective policies, procedures and practices are in place to support data integrity, including the integrity of data provided to customers for use in regulatory filings.
Regarding information provided to customers, establish form/process to document review and approval of data ensuring that they are complete, accurate and traceable to the raw data.
Ensure the procedures and practices are put in place to ensure that vendors and suppliers have an adequate data governance process in place.
Ensure a process is developed and utilized to identify, escalate and resolve suspected data integrity issues within the structure of the QMS. Participate in the process and ensure activities are documented within the QMS.
Support internal GMP audit team as necessary
Participate in review of regulatory agency inspection responses, customer audit responses and internal audit responses that are associated with potential data integrity concerns to ensure they meet regulatory requirements and expectations.
Provide Knowledge Management structure and content for data integrity items and ensure they are available to all Operations staff
Identify and maintain inventory of all policies and procedures that include data integrity relevant requirements
Identify and maintain collection of appropriate resource materials for all functional areas including laws, regulations, guidance, guidelines and directives
Serve as content SME for development of education/training in the area of data integrity by the training organization. Ensure that adequate education and training are provided and provides training to staff based on their functional responsibilities including:
In depth education on the fundamentals of cGMPs
General data integrity education for all staff
Specialized education for others including but not limited to laboratory analysts, data reviewers, manufacturing operators, managers, and GMP auditors
Provide ongoing periodic training / education updates to both general and specialized areas
Leverage expertise in the IT areas as appropriate, particularly for data review and auditor training.
Assist in establishing budgets for data integrity initiatives
Perform other duties as assigned.
Key requirements:
10+ years’ experience in cGMP Pharmaceutical or Biotechnology industry.
Knowledgeable about cGMP, GAMP, and industry requirements and standards
Excellent written and verbal communication skills.
Proficient at MS Office suite.
Embraces a culture of sharing knowledge and training others.
Effective at leading cross-functional teams and welcomes diversity of thought
Proficient at Quality Risk Management
Ability to understand different levels of data criticality and arrive at pragmatic solutions that are still compliant
Proficient at driving methods of change in achieving productivity improvement goals
Solid knowledge of data integrity gaps and mitigation strategies common in the industry
Solid knowledge of CMMS systems, preferably SAP Plant Maintenance module.
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.
The full-time base annual salary for this position is expected to range between $119,000 and $139,000. Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
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.
