Global CMO Clinical Packaging Site Manager (m/f/d)
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, with significant research and development functions located here. For our long-term client, F. Hoffmann-La Roche AG in Kaiseraugst, we are seeking a Global CMO Clinical Packaging Site Manager (m/f/d).
Background
As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures that packaging operations produce materials required by Roche's clinical trials seamlessly and on-time, while optimizing cost and quality. Within Production Enablement, the Global CMO Clinical Packaging Management team oversees the outsourced manufacturing portion of the Clinical Packaging portfolio. Contract Manufacturing Site Managers collaborate with contract manufacturers (CMOs) worldwide, Procurement, Clinical Planning, Quality, and other operations functions to develop and negotiate supply contracts and ensure product delivery from external manufacturing partners with optimal cost, quality, and speed. CMO Site Managers also drive the evolution and implementation of new systems and efficient internal and external processes in support of CMO production, aligned with the Pharma Vision of delivering 20 transformative medicines addressing diseases with the highest societal burden between 2020 and 2029.
Tasks & Responsibilities
- Serve as a Contract Manufacturing Organization (CMO) Site Manager, overseeing clinical drug labeling, packaging, and device assembly production outsourced by Roche to a global network of CMOs.
- Proactively manage CMO project onboarding, communications, timelines, and delivery performance for outsourced clinical packaging orders to meet supply chain needs, ensuring cost and quality objectives are met.
- Collaborate with Procurement and key stakeholders to prepare Requests for Proposal (RFPs) or Statements of Work (SOW), negotiate supply agreements, and select vendors for outsourced clinical packaging.
- Support leadership in defining outsourced supply strategies for product supply chains requiring a non-standard design.
- Oversee the budgeting process and submissions for CMO project variable costs.
- Partner with upstream functions and leaders to establish team scope and division of roles and responsibilities.
- Define, track, and report CMO team KPIs, driving successful network supply outcomes and representing the CMO function in the CD&OP process.
- Lead Supplier Relationship Management activities with CMO partners.
- Work with CMOs to ensure capability and capacity for on-time and predictable delivery of outsourced clinical packaging production.
- Create and maintain Purchase Orders for CMO production in the purchasing system.
- Review and approve CMO invoices.
- Perform pre and post-production order management for clinical CMO Packaging orders in the ERP system.
- Collaborate with internal cross-functional teams to understand needs and expectations for CMO offerings and performance.
- Champion process improvement opportunities and apply technical principles and expert knowledge to solve a broad range of supply chain issues.
- Serve as the subject matter expert and primary contact for key initiatives and projects related to CMO Clinical Packaging.
Must Haves
- 8+ years in the pharmaceutical industry, supply chain management, or manufacturing.
- Experience with clinical drug manufacturing or clinical supply chain management strongly preferred.
- Proficient knowledge and experience of SAP or ERP systems.
- BA/BS Degree, preferably in a technical, business, or supply chain field. A Master’s Degree is a plus.
- APICS and/or SCOR certification, or equivalent relevant experience.
- PMP/Operational Excellence/Six Sigma/Lean training is a plus.
- Solid understanding of the pharmaceutical industry and supply chain dynamics.
- Demonstrated skills in project planning, project management, and resource management.
- Strong analytical and problem-solving abilities with attention to detail.
- Ability to communicate clearly and professionally, both in writing and verbally (Excellent English skills - basic German skills beneficial).
- Flexibility to work varying hours to meet global needs.
What You Will Be Offered
- An opportunity to work in one of the world's leading pharmaceutical companies.
- A modern campus with green spaces and ample meeting areas.
- A central location in Basel.
- A varied job profile with diverse responsibilities.
- Further training opportunities through temptraining.
- The chance to work within a dynamic and motivated team.
Apply online using the form below. Only applications matching the job profile will be considered.