Risk Management Lead

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.

Risk Management Lead

The Risk Management Lead is a versatile technical role responsible for ensuring Global Risk Management and Data Integrity Risk Management principles are implemented globally at Lonza. The role requires strong risk management and data integrity background (including issuance of resulting CAPA and Change Control to support these programs), leadership capabilities, and the ability to collaborate effectively across departments to drive the successful execution of quality initiatives.

Key responsibilities:

• This role is engaged in providing support for risk processes (primary role) and as a backup for data integrity (both with a global focus)
• Evaluate and develop a Quality Maturity Matrix aligned with FDA guidance (and external customer request)
• Develop training content on QMM approaches as well as how to properly perform risk and data integrity assessments and associated mitigations
• Facilitate global risk assessments, as requested
• Work on a project to obtain the site risk registers, evaluate to harmonize reporting across the organization, and report associated risks in a normalized fashion
• Engagement of strong cross-functional relationships to drive global standardization of risk reporting processes (standardize how risks are quantified and summarized)
• Align DI Maturity Tools and Quality Maturity Tools in order to be able to report overall site risk to leadership
• Maintain the risk scoring tool (currently under development), Power BI platform
• Attend Data Integrity Governance meetings, provide backup support to the program focused on governance and maturity models with a focus on risk to Lonza, our customers, and our processes/systems
• Regulatory Information Board support and assistance with RISC activities to resolve gaps
• Update Global Governing Standards in response to regulatory changes and/or commitments.

Key requirements:

• Bachelor/ Master Degree in Biochemistry, Biology, Chemistry, Pharmacy or equivalent
• Proven hands-on experience in the development, implementation, maintenance  of maturity matrices/risk assessments in the pharma-biotech industry
• Broad work experience in QA, including skills in Risk Management and Data Integrity, CAPA and Change Control
• 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)
• Broad knowledge of GxP requirements (US FDA, EMA, MHRA, as examples)
• Excellent English skills, both written and spoken; knowledge of additional languages  is an advantage

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.

Compensation for the role will depend on a number of factors, including the location of the successful candidate, qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified indi