Leadership of the CPS Compounding Team at RDSZ in the safe, reliable, cost-effective and efficient production of the product portfolio for Immunochemistry and Clinical chemistry test assays, at our state of the art manufacturing facility, while fully engaged in an ongoing collaboration, leveraging/sharing within the Global Operations network especially at sister-sites in Mannheim & Penzberg.
Main Tasks & Responsibilities:
- Execute and on-time delivery according to the production plan, for the purpose of Process Validation and Commercial supply while enabling timely maintenance and calibration for the responsible process equipment and measurement devices
- Provide leadership and ensure development, compliance and maintenance of up to 45 qualified personnel within the department
- Coordination, management and implementation of respective training programs
- Comply with ISO 13485 as well as NMPA regulatory requirements in order to ensure the right to operate.
- Lead in the area of special improvement projects, harmonizing common practices across RDSZ manufacturing areas and in collaboration with relevant stakeholders and decision makers, especially MSAT, R&D & Quality
- Interface with German sister sites (Mannheim & Penzberg) to ensure uninterrupted, quality supply of product
- Implementation of specific projects in consultation with direct manager
- Communicate, inform and collaborate within stakeholders as a key decision maker and people leader
- Ensure that all applicable Safety, Health & Environment requirements are fulfilled to comply with corporate group policy and local legal requirements
- Ensure compliance with Roche’s Group Code of Conduct.
- Exemplify the Roche Values and Leadership Commitments
- Ensure adequate budgeting for operating costs, headcount and CAPEX
- Manage and control expenses and investments towards the set targets
- Master’s Degree in Biology, Immunology or Chemistry is required
- 10+ years leadership experience in the area of compounding/technical service in IVD/Pharma industry is required.
- Lean - Six Sigma Black Belt
- Global, cross-functional, projects and matrix organizations
- Project Management execution as leader and team member
- Understand delivery and acceptance of fast-paced project execution
- Demonstrate capability for problem solving, assertive decision making and sound judgement
- Excellent oral and written English
- Comfortable presentation to diverse, large groups
- Proven experience in concept planning & execution
- Ideal international work experience (preferably in Europe/Germany)
- Strong networking and interpersonal skills..