Head of MES Center of Excellence (Director)
United Kingdom, Slough
United States, Portsmouth (New Hampshire)
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 MES CoE Director will drive Global standards for EBR and lead the implementation of a Global MES Template in Growth Projects for the Mammalian/ Microbial, API and Small Molecules operations networks.
In collaboration with the business and IT partners, s/he will develop strategies and actionable plans that maximize the value from the use of our MES solutions.
Responsible for the selection, design, deployment and roll-out of global standards for the operations network, including infrastructure, asset and incident management.
Lead the effort to ensure operational functionality of the MES standard as well as compliance to cGMP in collaboration with Sites leadership teams, Global Quality Assurance and IT (security and infrastructure).
Leads, manages, coaches, motivates and guides a team of highly skilled MES experts.
Lead the Global MES CoE including; enabling capabilities, standards, governance framework and portfolio management.
Own the Lonza MES Template and ensure that’s maintained according to the TechOps Strategy and priorities.
Responsible to ensure that workforce plans, vendor management, budget management, customer change management, staff performance management and other internal processes are conducted professionally and in the best interests of our customers, teams, and other stakeholders.
Keep abreast of technical developments that may have application in the Pharma / biotech industry and promote the use of those that provide strategic business benefits.
Ensure team actively manages incidents, service requests, and change queues in compliance with Lonza processes.
Develop and continuous improvement of technical global standard for electronic batch recording.
Maintain and execute the MES roadmap and global deployment of the Lonza Target Architecture standards across sites.
Establish and manage a service to support manufacturing sites with the management of generic Master Batch Records and daily operations.
Liaison with Operations, Quality, Engineering, IT and Regulatory teams to ensure a compliant, lean and cross-functional approach to MES solutions.
Collaborate with all internal stakeholders including Senior Management, Functional Leaders, and Site Heads to gain alignment for MES strategy and to identify appropriate trainers and subject matter experts.
Ensure organizational effectiveness, achievement of business objectives and regulatory compliance.
GxP systems implementation or software development life cycle as well as supporting project and validation methodologies (CSV).
Professional experience in the pharmaceutical/biotech industry and expertise in GxP and regulations such as 21 CFR Part 11.
Strong coaching, mentoring, and influencing skills. Strong leadership and people management skills, inspiring and empowering leadership style.
Demonstrated experience effectively collaborating with customers and cross-functional teams to deliver superior business outcomes
Highly customer-focused, with demonstrable stakeholder management experience and passionate about delivering high quality innovative solutions and services that meet business needs, which are readily scalable
A proven track record of running high performing environments, including virtual teams.
Innovative, responsible, and reliable with a highly developed strategic mindset
Able to contribute at a functional leadership level beyond own immediate area of responsibility with strong communication skills and ability to forge relationships with a wide range of colleagues across the globe
Experience in managing change initiatives with the commitment to implement change within the organization
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.