Global Head CQV GE

Today, Lonza is a global leader in life sciences operating across five 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.

We are looking for a Global Head of CQV / CSV GE (Global Engineering).

Role Purpose:

The Global Head CQV - CSV GE will drive people management, project management, solution development, standardization, enhancement and operational support across all projects where commissioning, qualification and validation (CQV) / computer system validation (CSV) activities are applicable.

The position is globally responsible that world class standards and practices in the area of CQV are developed, maintained and applied across all GE projects globally. In particular he/she develops and deploys a suite of global guidelines and rolls‑out the digital CQ platform not just for CAPEX projects but also for life‑cycle activities.

The COEs under the lead of the global head define the CQV strategy, provide training and oversight to project teams and enable a smooth hand‑over of the assets to operations.

Key Responsibilities:

• Responsible to develop global standards and processes in the area of commissioning, qualification and validation (CQV)
• Responsible for rolling out the Lonza CQV approach and the standardized procedures
• Provide oversight of all CQV activities to the GE projects globally through the regional CQV leads. Ensure the regional GE project delivery teams are aware and trained on Lonza's CQV approach, the CQV blueprint and follow global standards
• Provide leadership and set strategy to the regional CQV and COE teams including the CSV COE
• Through the regional CQV leads, support GE project teams in business related quality and compliance topics, conduct regular feedback sessions on ongoing projects and sharing lessons
• Working closely with GE Engineering, Construction and QA to align on CQ Deliverables
• Ensure all GE projects have a solid CQV strategy and respective plans in place. Assist projects hands‑on in early project phases
• In cooperation with the project teams and procurement, find local or global partners to assure adequate staffing, enhance efficiency and reduce costs of CQV activities. Assist and provide documentation for efficient CQV RFPs
• Track the progress of GE projects portfolio in the area of CQV, communicate potential issues and take leadership presenting corrective actions in an open and timely manner
• Responsible for managing a global team of direct reports including hiring, performance management, training & development of team members as well as proposing organization staffing/structure needs as required. Act as coach & mentor to CQV experts & specialists
• Deploy the Digital CQ platform system globally and manage a team, maintaining the centralized C&Q standards, developing Templates and testcases in the digital validation system.
• Lead or global initiatives in the area of CQV as needed to continuously improve CQV processes, standards and execution
• Bridge Relationship with GE Business Integration & Delivery
• Manage global stakeholder from sites, business units, QA, authorities and others

Key Requirements, Qualifications, Skills & Behavior:

• Technical Degree in Engineering or applied science
• Fluent in English and German
• Several years Leading / managing successful deployment of CQV activities, CAPEX projects, QA activities and/or manufacturing operations in a regulated environment within global organizations
• Deep understanding of the actual landscape of pharmaceutical manufacturing operations and technologies
• Profound Experience in commissioning of pharma manufacturing assets having lead cross‑functional C&Q teams from MC to PQ
• Ideally having held the role of C&Q manager on a large scale CAPEX project
• Project management skills and knowledge about project controls processes
• Professional experience in the pharmaceutical/biotech industry and expertise in GxP and regulations such as 21 CFR Part 11
• GxP systems implementation or software development life cycle as well as supporting project and validation methodologies (CSV)
• Experience in and understanding of CAPEX project life cycle, engineering, construction, commissioning and qualification activities and processes
• Strong coaching, mentoring, and influence skills. Strong leadership and people management skills, inspiring and empowering leadership style
• 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 colleag

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