Global CMO Clinical Packaging Site Manager (m/f/d)
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, with vital 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 can seamlessly produce materials required for Roche's clinical trials on time, while optimizing cost and quality. Within Production Enablement, the Global CMO Clinical Packaging Management team oversees the outsourced manufacturing segment of the Clinical Packaging portfolio. Contract Manufacturing Site Managers collaborate closely with contract manufacturers (CMOs) worldwide, as well as Procurement, Clinical Planning, Quality, and other operations functions, to develop and negotiate supply contracts and ensure product delivery from external partners at optimal cost, quality, and speed. Furthermore, CMO Site Managers drive the evolution of new systems and efficient internal and external processes, supporting CMO production and the Pharma Vision to deliver 20 transformative medicines that address diseases with the highest societal burden from 2020 to 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 worldwide CMOs.
- Proactively manage CMO project onboarding, communications, timelines, and delivery performance to meet supply chain needs while ensuring cost and quality objectives are met.
- Collaborate with Procurement and other key stakeholders to drive the preparation of 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.
- Own the budgeting process and submissions for CMO project variable costs.
- Partner with upstream functions to establish team scope and division of roles and responsibilities (e.g., device CMO team), and own any support models and service provision to other Roche CMO teams.
- Define, track, and report on 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 capability and capacity with CMOs to enable 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.
- Perform pre and post-production order management for clinical CMO Packaging orders within the ERP system.
- Collaborate with internal cross-functional teams to understand expectations for CMO offerings and performance.
- Identify and advocate for internal and external process improvement opportunities, leveraging collaboration skills and expert knowledge to address a wide 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 pharma industry, supply chain management, or manufacturing.
- Experience in clinical drug manufacturing or clinical supply chain management is strongly preferred.
- Proficient knowledge and experience with SAP or ERP systems.
- BA/BS Degree, ideally 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, or Lean training is advantageous.
- Solid understanding of the pharma industry, supply chain, contract manufacturing, and/or clinical manufacturing activities.
- Demonstrated skills in project planning, project management, and/or resource management.
- Ability to lead teams and projects from initiation to delivery.
- High degree of cultural awareness and social competence for successful internal/external collaboration.
- Strong analytical and problem-solving skills, with a high attention to detail and understanding of systems.
- Proven track record of integrity and instilling confidence in colleagues and teams.
- Ability to operate independently and set priorities under general leadership direction.
- Proven ability to make sound decisions and be accountable for them.
- Ability to apply cross-functional business expertise toward achieving organization-level objectives and addressing complex issues.
- Excellent communication skills, both written and verbal (Excellent English; basic German is beneficial).
- Effective communicator at all levels, with strong presentation skills.
- Flexibility to begin work as early as 7 AM and finish as late as 6 PM (Switzerland) or work from 10 AM-Noon (Mississauga), as required to meet global demands.
What You Will Be Offered
- An opportunity to work with one of the world's leading pharmaceutical companies.
- A modern campus featuring ample green spaces and meeting areas.
- Central location in Basel.
- A varied job profile.
- Further training opportunities through temptraining.
- Collaboration within a dynamic and motivated team.
If you are interested, please apply online using the form below. Note that only applications matching the job profile will be considered.