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 the materials required for Roche's clinical trials seamlessly, on-time, and while optimizing costs and quality. Within this framework, the Global CMO Clinical Packaging Management team oversees the manufacturing of the outsourced portion of the Clinical Packaging portfolio. Contract Manufacturing Site Managers collaborate closely with contract manufacturers (CMOs) worldwide, as well as with Procurement, Clinical Planning, Quality, and other operational 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 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 achieved.
- Collaborate with Procurement and key stakeholders to drive the preparation for 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 that require a non-standard design.
- 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 (e.g., device CMO team). Own processes for support models and service provisions to other Roche CMO teams.
- Define, track, and report CMO team KPIs, and actively drive successful network supply outcomes while 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 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 activities for clinical CMO Packaging orders in the ERP system.
- Collaborate with internal cross-functional teams to align on expectations for CMO offerings and performance.
- Identify and champion internal and external process improvement opportunities, applying collaboration skills and expert knowledge to resolve a broad range of supply chain issues.
- Represent CMO Clinical Packaging as a Subject Matter Expert (SME) and primary contact on key initiatives and projects.
Must Haves
- 8+ years 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, contract manufacturing, and/or clinical manufacturing activities.
- Demonstrated skills in project planning, management, and resource management.
- Ability to apply experience gained from leading teams and/or projects from initiation to delivery.
- High degree of cultural awareness required for successful internal/external collaboration with partners across different cultures and countries.
- Strong analytical and problem-solving skills, high attention to detail, and an understanding of systems.
- Proven integrity and ability to instill confidence in colleagues and teams.
- Capability to operate independently and set priorities under general leadership direction.
- Track record of self-reliance in decision-making and accountability for outcomes.
- Ability to apply cross-functional business expertise towards achieving organization-level objectives and addressing complex problems.
- Effective communicator at all levels; excellent written, verbal, and interpersonal communication skills, with proficiency in English (basic German skills are beneficial).
- Flexibility to start work as early as 7 AM (SSF employees), finish work as late as 6 PM (Switzerland employees), and work from 10 AM to Noon (Mississauga employees) as needed to meet the demands of a global environment.
What You Will Be Offered
- An opportunity to work in one of the world's most significant pharmaceutical companies.
- A modern campus with ample green spaces and meeting areas.
- Central location in Basel.
- A varied job profile with diverse responsibilities.
- Further training opportunities through temptraining.
- A chance to work in a dynamic and motivated team environment.
If you are interested, please apply online using the form below. Please note that only applications matching the job profile will be considered.