United States, Hayward (California)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
DMS Administrator -
- Ensure PQS is designed to meet Regulatory, Customer and GROUP requirements and is effectively implemented on site.
- Provide training for PQS at site level. Utilize knowledge of GMP and quality processes to actively identify, suggest, participate in and manage continuous improvement to ensure that PQS remains effective, efficient, simple and compliant.
- Provide guidance and coaching to system users.
- Act as quality approver.
- Monitor and interpret quality metrics and ongoing quality trends to provide information to the site to ensure action is taken in a timely manner to address trends, highlighted issues etc.
- Actively develop, mentor, train and enforce a site GMP culture within Operations. Support regulatory and customer audits as SME for PQS.
- Identify opportunities for GMP compliance training and awareness campaign - design, develop and deliver. Enable site operations performance by managing and supporting GMP issues through the Pharmaceutical Quality System and site governance mechanisms.
- Supporting Senior QA leadership to drive continuous improvement
- BSc in Science discipline (or equivalent experience). Qualification in Quality would be an advantage.
- Significant industry experience within quality and QA.
- Significant experience in the design, implementation and ongoing management of Pharmaceutical Quality Management Systems.
- Experience of working on and / or run continuous improvement projects on a company wide basis would be an advantage.
- Line management or supervisory experience would be an advantage.
- Familiarity with Trackwise and Documentum.
- Good decision-making and problem solving skills.
- Good knowledge of GMP regulations and guidelines.
- Good organizational & planning skills.
- Ability to interpret and translate GMP guidelines into effective processes and procedures.
- Ability to meet strict deadlines. Good project management skills.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievement 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.