Expert QA (Data Integrity)

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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

What you'll do:

• Lead the Data Integrity Program for the site and act as a subject matter expert regarding Data Integrity.

• Develop the site Data Integrity Plan, including prioritized activities, responsibilities, and timelines for activity completion.

• Ensure data quality and consistency within the site by strictly supervising to meet Lonza and regulatory requirements.

• Follow data integrity notification processes when problems arise to maintain flawless data standards.

• Reduce the risk of regulatory findings or observations related to data integrity through proactive measures.

• Lead the Data Integrity Risk Assessment and support the site to build Corrective and Preventative Actions based on the assessment outcomes.

• Drive site remediation efforts and communicate any delays to the site Quality Council and Global DI Leads to ensure transparency and accountability.

• Collaborate with site personnel to continually identify and leverage opportunities to improve the quality of data management and secure data protection.

• Actively participate in the Global DI network and DI Forum to share insights and approaches with similar sites under corporate/regulatory requirements.

• Engage and partner with other DI leads to share lessons learned and address concerns.

• Contribute to group tracking for DI issues and roll out Data Integrity training, suggesting improvements where necessary.

• Participate in gap assessments to ensure that regulatory findings at Lonza and within the industry are monitored and corrected.

• Take part in troubleshooting or improvement programs and initiatives to refine data integrity practices.

• Represent Quality in defining and implementing global standards.

• Serve as a subject matter authority (SME) in Data Integrity.

• Represent Quality in various CAPEX project teams to ensure quality standards are upheld.

• Undertake any other tasks as assigned by the manager.

What we’re looking for:

• Degree or equivalent experience in Science from a recognized institution with extensive experience in a Quality unit within the pharmaceutical or biotech industry.

• Proven knowledge and experience in the practical and theoretical requirements of validation programs, including Data Integrity in a GMP facility.

• Strong appreciation of cGMP in biopharmaceutical manufacturing.

• Experience with pharmaceutical Quality Systems, including change control, deviation, and CAPA.

• Knowledge of regulatory requirements and local Codes & Standards such as ISPE, 21 CFR Part 11, EU GMP Annex 11, GAMP5, and ICHQ7 principles.

• Outstanding leadership and interpersonal skills.

• Able to communicate complex information concisely, build good relationships with internal customers and support functions like QC, QA, Engineering, and Operations.

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 achieve 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.