Global CMO Clinical Packaging Site Manager (m/f/d)
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, housing important research and development functions. We are currently seeking a Global CMO Clinical Packaging Site Manager (m/f/d) for our long-term client, F. Hoffmann-La Roche AG, located in Kaiseraugst.
Background:
As part of the PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures seamless, on-time packaging operations that meet the material requirements for Roche's clinical trials, all while optimizing cost and quality. Within this function, the Global CMO Clinical Packaging Management team is responsible for overseeing the outsourced portion of the Clinical Packaging portfolio. Contract Manufacturing Site Managers collaborate with contract manufacturers (CMOs) worldwide, alongside 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. Additionally, CMO Site Managers drive the evolution and implementation of new systems and enhance internal and external processes in support of CMO production, aligning with the Pharma Vision to deliver 20 transformative medicines targeting society's most pressing diseases between 2020 and 2029.
Tasks & Responsibilities:
- Serve as the Contract Manufacturing Organization (CMO) Site Manager, organizing and overseeing outsourced clinical drug labeling, packaging, and device assembly production.
- Proactively manage CMO project onboarding, communications, timelines, and delivery performance to meet supply chain needs while adhering to cost and quality objectives.
- 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 innovative designs.
- Oversee the budgeting process and submissions for variable costs associated with CMO projects.
- Work with upstream functions and leaders to establish team scope and define roles and responsibilities within the CMO team.
- 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.
- Ensure CMOs possess the capabilities and capacity for timely and predictable delivery of outsourced clinical packaging production.
- Create and maintain Purchase Orders for CMO production within the purchasing system.
- Review and approve CMO invoices.
- Manage pre and post-production order processes for clinical CMO Packaging orders in the ERP system.
- Collaborate with internal cross-functional teams to understand expectations for CMO offerings and performance.
- Identify and advocate for both internal and external process improvement opportunities, applying collaboration skills and expert knowledge to drive solutions to a range of supply chain issues.
- Act as the Subject Matter Expert (SME) and primary contact for CMO Clinical Packaging on key initiatives and projects.
Must Haves:
- 8+ years of experience in the pharmaceutical industry, supply chain management, or manufacturing.
- Strong experience with clinical drug manufacturing or contract manufacturing management is preferred.
- Proficient in SAP or ERP systems.
- BA/BS Degree, preferably in a technical, business, or supply chain field; Master’s Degree is a plus.
- APICS and/or SCOR certification, or equivalent relevant experience.
- PMP/Operational Excellence/Six Sigma/Lean training is advantageous.
- Solid understanding of the pharmaceutical industry, supply chain, and clinical manufacturing activities.
- Demonstrated project planning and resource management skills.
- Ability to independently lead teams and projects from initiation to delivery.
- Cultural awareness and social competence for successful internal and external collaboration.
- Strong analytical and problem-solving skills with high attention to detail.
- Proven integrity and ability to instill confidence in colleagues and teams.
- Ability to operate independently and prioritize tasks effectively under general leadership direction.
- Proficient communication skills in English, both written and verbal; German basic skills are beneficial.
- Effective communicator at all organizational levels with excellent presentation skills.
- Flexibility to start work early or finish late as needed to accommodate global operations.
What You Will Be Offered:
- An opportunity to work in one of the world's most significant pharmaceutical companies.
- A modern campus featuring ample green spaces and collaboration areas.
- A central location in Basel.
- A diverse job profile with rich learning experiences.
- Further training opportunities through temptraining.
- The chance to be part of 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.