Global CMO Clinical Packaging Site Manager (m/f/d)
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, hosting crucial research and development functions. For our long-term client, F. Hoffmann-La Roche AG, located 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 the materials required for Roche's clinical trials seamlessly, on time, and while optimizing cost and quality. The Global CMO Clinical Packaging Management team is responsible for overseeing the outsourced manufacturing portion of the Clinical Packaging portfolio. Contract Manufacturing Site Managers work closely with contract manufacturers (CMOs) worldwide, as well as with Procurement, Clinical Planning, Quality, and other operations functions to develop and negotiate supply contracts. They ensure the delivery of products from external manufacturing partners with optimal cost, quality, and speed. Additionally, CMO Site Managers drive the evolution and implementation of new systems and efficient processes, supporting CMO production aligned with Roche's Pharma Vision to deliver transformative medicines addressing significant societal health burdens from 2020 to 2029.
Tasks & Responsibilities
- Serve as a Contract Manufacturing Organization (CMO) Site Manager, organizing and overseeing 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, ensuring cost and quality objectives are met.
- Collaborate with Procurement and key stakeholders to prepare Requests for Proposals (RFPs) or Statements of Work (SOW), negotiate supply agreements, and select vendors for outsourced clinical packaging.
- Support leadership in defining outsourced supply strategies for non-standard design product supply chains.
- Own 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; actively drive successful network supply outcomes and represent the CMO function in the CD&OP Process.
- Lead Supplier Relationship Management activities with CMO partners.
- Ensure capability and capacity with CMOs 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.
- Manage pre and post-production order processes 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.
- Identify and champion internal and external process improvement opportunities.
- 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 pharmaceutical industry, supply chain management, or manufacturing.
- Experience in clinical drug manufacturing, clinical supply chain, or contract manufacturing management is strongly preferred.
- 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 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 skills in project planning, project management, and resource management.
- High degree of cultural awareness and social competence, necessary for effective collaboration with diverse partners.
- Strong analytical, problem-solving skills, and high attention to detail.
- Proven track record of integrity and the ability to instill confidence in colleagues and teams.
- Ability to operate independently and set priorities under general leadership direction.
- Effective communication skills in English, both written and verbal; basic German skills are beneficial.
- Flexibility in work hours to accommodate the needs of a global environment, which may include starting as early as 7 am or finishing as late as 6 pm.
What You Will Be Offered
- An opportunity to work with one of the world’s leading pharmaceutical companies.
- A modern campus featuring abundant green spaces and meeting areas.
- A central location in Basel.
- A varied job profile with opportunities for further training through temp training.
- An environment characterized by 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.