Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there\\xe2\\x80\\x99s 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\\xe2\\x80\\x99s the kind of work we want to be part of. If you are interested to join us apply for this Standard Implementation Lead position.

Key responsibilities:

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• Responsible for working with Process Owners across 6 pillars (Quality, Production, Laboratory, Materials, Facilities/Equipment/Utilities, and Packaging/Labeling) to generate gap assessments to ensure global standards are implemented at site level

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• Lead the Document Governance Board to ensure effective change management of documentation with regards to proper scoping of standards, determining key reviewers and approvers, assessing training needs, identifying risks, and evaluating impact to related standards

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• Ensure a simplified and robust document hierarchy, and implement tools to find the right document at the right time

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• Review and reconciliation of completed gap assessments, including reporting of metrics related to the program (gap assessment completion, effectiveness checks, corrective actions)

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• Support the sites in the implementation of the global processes and procedures, identify where standards and LEAN processes can be implemented while removing duplicated or conflicting requirements

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• Engagement of strong cross-functional relationships to drive global standardization

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Key requirements:

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• Bachelor/ Master Degree in Biochemistry, Biology, Chemistry, Pharmacy or equivalent

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• Proven hands-on experience in the development, implementation, maintenance of standards in the pharma-biotech industry

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• Broad work experience in QA and in depth knowledge of Quality Management Systems across different GxP areas and global health authority regulations (drug substance, drug product, cell and gene therapies, medical device, excipients, nutritional products, custom media products and reagents)

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• Excellent knowledge of computer systems and applications with demonstrated skills in the use of information management systems in a GxP environment (Trackwise, Document Management Systems) and related tools (Power BI, Teams, Excel)

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• Operational experience in chemical and/or biological GMP manufacturing (drug substance, drug product etc) is a plus

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• Broad knowledge of GxP requirements (US FDA, EMA, MHRA, as examples)

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• Excellent English skills, both written and spoken; knowledge of additional languages is an advantage

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Every day, Lonza\\xe2\\x80\\x99s 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

Reference: R57268