Global CMO Clinical Packaging Site Manager (m/f/d)
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, hosting crucial research and development functions. We are seeking a Global CMO Clinical Packaging Site Manager (m/f/d) for our esteemed client, F. Hoffmann-La Roche AG in Kaiseraugst.
Background
As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures that packaging operations can seamlessly produce materials required for Roche's clinical trials, on-time and while optimizing cost and quality. Within Production Enablement, the Global CMO Clinical Packaging Management team oversees the outsourced portion of the Clinical Packaging portfolio. Contract Manufacturing Site Managers collaborate closely with contract manufacturers (CMOs) around the globe, Procurement, Clinical Planning, Quality, and other operational functions to develop and negotiate supply contracts, ensuring 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, supporting CMO production and the Pharma Vision to deliver 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, organizing and overseeing the clinical drug labeling, packaging, and device assembly production outsourced by Roche to a network of worldwide CMOs.
- Proactively manage CMO project onboarding, communications, timelines, and delivery performance for outsourced clinical packaging orders to meet supply chain needs while ensuring cost and quality objectives are met.
- Partner with Procurement and other key stakeholders, drive the preparation for Requests for Proposal (RFPs) or Statements of Work (SOW), negotiate supply agreements, and select vendors for outsourced clinical packaging.
- Actively support leadership in defining outsourced supply strategies for non-standard product supply chains.
- Own the budgeting process and submissions for CMO project variable costs.
- Collaborate with upstream functions to establish team scope and division of roles and responsibilities (e.g., device CMO team).
- Define, track, and report CMO team KPIs, actively driving successful network supply outcomes and representing the CMO function in the CD&OP Process.
- Lead Supplier Relationship Management activities with CMO partners.
- Ensure CMOs have the capability and capacity for on-time and predictable outsourced clinical packaging production delivery.
- Create and maintain Purchase Orders for CMO production in the purchasing system.
- Review and approve CMO invoices.
- Manage pre and post-production order management for clinical CMO Packaging orders in the ERP system.
- Collaborate with internal cross-functional teams to understand the needs and expectations for CMO offerings and performance.
- Identify and champion internal and external process improvement opportunities, applying collaboration skills, technical principles, and expert knowledge to drive solutions to a broad range of supply chain issues.
- Represent CMO Clinical Packaging as a Subject Matter Expert and primary contact on key initiatives and projects.
Must Haves
- 8+ years of experience in the pharma industry, supply chain management, or manufacturing.
- Strong preference for experience in clinical drug manufacturing, clinical supply chain, or contract manufacturing management.
- Proficient knowledge and experience with 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 relevant equivalent experience.
- PMP/Operational Excellence/Six Sigma/Lean training is advantageous.
- Solid understanding of the pharma industry, supply chain, contract manufacturing, and clinical manufacturing activities.
- Demonstrated skills in project planning, project management, and/or resource management.
- Ability to leverage experience from leading teams and/or projects from initiation to delivery.
- High cultural awareness and social competence for successful internal/external collaboration with partners from diverse backgrounds.
- Strong analytical and problem-solving skills, with a keen attention to detail and understanding of systems.
- Demonstrated integrity and ability to instill confidence in colleagues and teams.
- Capacity to operate independently and set priorities under general leadership direction.
- Proven self-reliance in making sound decisions and accountability for those decisions.
- Ability to apply cross-functional business expertise towards organizational objectives and to address complex problems.
- Exceptional communication skills in English; German basic skills are beneficial.
- Effective communicator across all levels with excellent written, oral, interpersonal, and presentation skills.
- Flexibility to accommodate varying work hours in a global environment.
What You Will Be Offered
- An opportunity to work in one of the world's leading pharmaceutical companies.
- A modern campus with ample green spaces and meeting areas.
- A central location in Basel.
- A diverse job profile with opportunities for further training through temptraining.
- The chance to work in a dynamic and motivated team.
If you are interested, please apply online using the form below. Only applications matching the job profile will be considered.