Global Quality Control Process and Data Management Lead, Quality Enabling Functions
vor 1 Woche
**Location. The actual location of this job is in Basel or Visp, Switzerland, or Portsmouth, US.**
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 job holder is accountable for translating QC strategies in respective processes and for assuring related data management is done in an efficient and lean way. The job holder identifies process deficiencies and supports cross team as well as cross functional in improving those to bring them to a state of the art setup.
**What you’ll get**:
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- A variety of benefits dependent on role and location.
**What you’ll do**:
- Provide strategic and operational leadership and management for establishing QC processes and solutions with a focus on data management and software tools, as defined in the Quality Strategy for the entire Lonza network (cross-platform).
- Lead and coordinate strategic, tactical and operational activities and projects together with the QC business process owner in the assigned area.
- Keep close contact and collaborate with IT as well as Digital QEF to assure appropriate prioritization and implementation of testing solutions in related area.
- Oversee Lonza QC analytical software tools in use and related roadmap for keeping them lean and state of the art, ensure alignment and realization of cross platform benefits, in cooperation with other QC QEF functions.
- Work closely with cross-functional, platform and global teams, including IT, Operation, Supply Chain, Finance, Procurement etc. to align operational initiatives with business objectives.
- Provide guidance and support teams during transition periods, addressing concerns and facilitating training as needed.
- Act as global QC business processes owner for selected processes and as global QC system owner for assigned software solutions.
**What we’re looking for**:
- Experience: 5+ years direct job related experience in Analytical Testing (thereof min. 3 years in QC) and Quality Management of products regulated by FDA CBER or CDER or EMA. At least 5 years in leadership positions.
- Skills: 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. Strong knowledge of current industry trends and the ability to use the latest technologies. Working knowledge in Analytical Testing (method development, validation, verification, improvement etc.) and related software tools. Excellent organizational and computer software skills. Able to challenge the status quo and to drive activities in a matrix organization.
- Education: Bachelor degree in Life Sciences, Engineering or Quality Management or related science discipline. Master degree or PhD preferred. Knowledge in general LEAN principles, belt certification a plus.
- Language: English business fluent, additional German a plus.
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.
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