Location: Porriño, Basel - Stücki; Portsmouth, NH; Singapore; Slough; Stein; Vacaville, CA ; Visp (Hybrid)
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.
The Global QA, QEF plays a pivotal role in providing strategic and operational leadership for establishing lean batch disposition standard process and defining the tactical implementation of QA strategic projects consistently across all Lonza sites. This role will act also as a SPOC for the defined business platform while creating a network, building a high-performance culture and engaging work environment.
What you’ll get:
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
What you’ll do:
Provide strategic and operational leadership and management for establishing QA lean processes defined in the Quality Strategy for the entire Lonza network.
Drive and oversee global QA Lean processes tactical plan and sustainable implementation in close collaboration with all sites and QA specific teams.
Accountable for developing/maintaining a compliant and effective industry-standard batch disposition strategy across the Lonza network.
Establish and lead a lean and efficient Site Quality risk mitigation governance program at Lonza to enable standard site risk mitigation plans and ensure preventive/ corrective actions are globally implemented (as appropriate) to reduce the risk of inspection/ customer audits observations across the Lonza network.
Forge strong relationships with other departments (e.g. QMS, Quality Compliance & Audit Management, QC , QA , MSAT, Manufacturing…) to foster a process of continual improvement and information sharing.
Build a high-performance culture and engaging work environment, influencing the Integrated Biologics sites.
Build the tactical plan and goals for QA strategic projects.
What we’re looking for:
Academic degree in Life Sciences or any related field.
Profound direct job related experience in GMP manufacturing and Quality management of products regulated by FDA CBER or CDER or EMA.
Substantial experience in leadership positions.
Expert knowledge of GxP, ISO Standards, FDA regulatory requirements applicable to FDA regulated products; European regulatory requirements as well as other authorities as applied to biologicals and sterile product manufacturing.
Lean Six Sigma Green Belt Certification preferred.
Empathy and resilience. Excellent communication skills at all levels in 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.
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What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
