Global Director, Quality Management Systems

Posted 5 Days Ago
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3 Locations
Senior level
Pharmaceutical
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization.
The Role
The Global Director, Quality Management Systems is responsible for the life cycle management of global Quality processes, driving continuous improvement, developing training packages, supporting implementation at sites, and engaging in regulatory inspections and audits through collaboration with a global network of experts.
Summary Generated by Built In

 

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 Global Director, Quality Management Systems (QMS) is the global process owner of Lonza’s core Quality processes. In this role you build and continuously improve efficient and effective global Quality processes in close collaboration with the Lonza network, which meet the business needs and which are in line with regulatory requirements and industry best practices. You are a member of the Global QMS/Performance team.

Please note that the role can be based in any of our major locations in US or Europe as long as the candidate sticks to the Hybrid Work Policy - being on site 3 days each week.

Key Responsibilities:

  • Responsible for the life cycle management of the owned global GxP Quality processes as well as building and leading a global network of subject matter experts to promote best practice sharing and continuous improvement.

  • Drive continuous improvement of core Quality processes (e.g training, deviation etc) at a global level in combination with improvements for the respective corporate electronic system.

  • Development of effective training packages and deliver trainings required for the global implementation of those processes.

  • Support the sites in the implementation of the global Quality processes and procedures.

  • Support regulatory inspections and customer audits for the owned global Quality processes.

  • Engagement of strong cross-functional relationships to drive global quality system requirements.

Key Requirements:

  • Bachelor's is required. Master's Degree in Biochemistry, Biology, Chemistry, Pharmacy or equivalent is preferred.

  • Proven hands-on experience in the development, implementation, maintenance and governance of modern corporate Quality Systems and electronic tools in the pharma-biotech industry.

  • Broad work experience in QA and in depth knowledge of Quality Systems across different GxP areas and global health authority regulations (drug substance, drug product, medical device, excipients, nutritional products).

  • Excellent knowledge of computer systems with demonstrated skills in the use of information management systems in a GxP environment (eQMS, eDMS, etc.).

  • Operations experience in chemical and biological GMP manufacturing (drug substance, drug product etc) is a plus.

  • 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.

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 individual with disability, protected veteran status, or any other characteristic protected by law. 

The Company
HQ: Basel
0 Employees
On-site Workplace
Year Founded: 1897

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.

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