Head Global Quality Systems and Compliance DPS
☞ PharmiWeb.jobs: Global Life Science Jobs
View: 143
Update day: 29-03-2024
Location: Basel Basel-Stadt BS
Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software
Industry: Staffing Recruiting
Position: Director
Job type: Full-time
Job content
Does the idea of working within an international and well established company that is active in over 100 countries around the world, where you will work only with professional people and top notch products appeals to you?Do you want to have great financial benefits and the opportunity for career progression as never before?Then this may be the career opportunity you have been looking for!The Role- 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 Processes used in DPS are fully aligned with DPQ 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: 13-05-2024
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