Head Global Quality Systems and Compliance DPS Growth Project 80-100% (m/f/d)
View: 171
Update day: 10-04-2024
Location: Basel Basel-Stadt BS
Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software
Industry: Pharmaceutical Manufacturing
Job type: Full-time
Job content
Switzerland, BaselSwitzerland, SteinToday, 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.Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position Head Global Quality Systems and Compliance DPS Growth Project 80-100% (m/f/d).Providing strategic leadership for the entire Drug Product Services (DPS) Quality Management System (QMS) and Compliance Principles in line with the regulations as well as (lean) six sigma principles to ensure that the compliance positioning of DPS is accurate and Customer experience is best in classKey Responsibilities- Design a local to global Quality System Strategy for DPS involving relevant stakeholders to define a best in class endpoint.
- Ensure consistency of the document framework (guidance documents, standards, SOPs), as well as accurate positioning in light of current regulatory expectations and anticipated industry trends
- Tailor the global system framework to the endpoint of a highly efficient, best in class newly built facility and ensure execution on the ground
- Leverage Network / Benchmark Learnings and apply to the newly built Facility QA Approach, for e.g among others award best in class practices (Raykoon Steel with Pride)
- Lead project teams to ensure Lonza Processes used in DPS are fully aligned with DP Q standards and HA regulations.
- Providing guidance, expertise and coaching, assisting sites and their teams for policies, procedures and specifications
- Serve as senior Drug Product Quality expert, providing solid, well-informed, actionable Quality support to the Drug Product Services BU
- Serve as a Coach / Mentor for Network Key Talents in order to ensure talents development.
- Academical degree (Bachelor or higher) in a Life Sciences, Engineering or Quality Management or related science discipline
- Substantial working experience in GMP manufacturing and Quality Management Systems of products regulated by FDA CBER or CDER or EMA
- Substantial experience in a leadership positions
- Lean Six Sigma Experience (Green/Black Belt Preferred), ability to design data driven Governance Systems
- Experience in aseptic processing/sterile manufacturing
- Fluency in English, German is an asset
Deadline: 25-05-2024
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