About this role
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 Compliance and Risk Management Governance and Intelligence.
Role Purpose:
The Global Head of Compliance and Risk Management Governance and Intelligence is critical for driving and overseeing the successful execution of strategic Quality Compliance programs/projects in alignment with the LGQ, IT, Operations, and the Quality Enabling Functions. This role is responsible for Lonza Quality Plan preparation and governance, managing the overall Compliance & Risk Management planning and reporting processes, facilitating Compliance, cross functional, and Global Quality Councils and serves as the touchpoint for to the leadership communications. The role serves as an ambassador and change agent for Compliance and Quality Excellence strategy and execution, in alignment with Lonza strategic imperatives, across platforms, functions, and regions.
Key Responsibilities:
Risk Management Framework Governance:
Lead the governance framework providing guidance and support to managers across platforms and functions.
Develops content for and facilitates strategic monthly leadership team meetings, as may be required.
Supports development and monitoring of global Quality Councils, including action tracking/minutes and Quality Plans.
Oversees Compliance programs/projects from initiation through to completion.
Monitors program/project progress and performance, ensuring timely delivery and quality outcomes.
Establishes/maintains project management standards and methodologies within in alignment with the One Lonza Vision Operates as SME/SPOC for competency areas, supporting troubleshooting, audits & inspections, etc. as required.
Support sites and business platforms during regulatory inspections, complex investigations, and escalated compliance topics, as needed.
Works closely with Compliance Head to complex manage escalations and address Executive leadership needs.
Global Execution of Quality Compliance & QMS Strategy:
Ensure operational execution of all strategic initiatives within Compliance & QMS, driving standardization and performance improvement.
Drive and lead the implementation of change management within operational planning to embed new processes, systems, and ways of working.
Oversee the development, monitoring, and reporting of the Lonza Quality Plan, ensuring visibility and accountability across functions.
Monitor and drive global improvements benchmarking, and proactive risk mitigation.
Data Analysis and Reporting:
Prepare and present detailed reports on strategic Quality program/project performance, risk status and operational metrics.
Manage the business reporting process (e.g., weekly huddle reports, monthly Quality reports, quarterly batch release review, etc.)
Responsible for development of Quality KPI and KQI targets and monitors performance monthly (or as may be required based on projects, priorities).
Stakeholder Engagement:
Build strong relationships with Global Quality, Regulatory Affairs, Operations, Finance, and platform/site leadership teams.
Use indirect leadership to drive decision-making and alignment in a matrixed global environment.
Facilitate executive-level discussions, ensuring balance between strategic priorities and operational realities.
Continuously influence stakeholders to maintain focus on long-term Quality Excellence goals.
Skills:
Strong leadership and team management skills.
Excellent project management skills.
Excellent Quality and Compliance experience.
Strong analytical and problem-solving abilities.
High attention to detail and organizational skills.
Superior communication and interpersonal skills.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and data analysis tools.
Key Requirements:
Qualifications & Experience
BSc or Masters degree in life science.
PMP Certification ICH Q8,9,10 Proficiency preferred.
Demonstrated success in managing large-scale, complex programs.
Experience in developing and implementing risk management frameworks.
Multisite leadership and Growth Projects experience
Successful track record with Health Authorities inspections (FDA, EMA, etc.).
Experience in managing complex multi-functional teams in a multinational business environment.
Experience in working in a multi-cultural and multi-national environment.
Able to work in a matrix-team structure.
Strong and proven leadership capabilities.
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.
About Lonza
Swiss contract development and manufacturing organization (CDMO) providing biologics, cell, and gene therapy production services.
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