Global CMO Clinical Packaging Site Manager (m/f/d)
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, with significant research and development activities based here. We are seeking a Global CMO Clinical Packaging Site Manager (m/f/d) for our long-term client, F. Hoffmann-La Roche AG in Kaiseraugst.
Background
As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures packaging operations can seamlessly produce materials required by Roche's clinical trials, maintaining on-time delivery 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 with Procurement, Clinical Planning, Quality, and other operations functions to develop and negotiate supply contracts, ensuring optimal product delivery from external manufacturing partners.
Additionally, CMO Site Managers drive the evolution and implementation of new systems and enhance both internal and external processes in support of CMO production, as part of Roche's Pharma Vision to deliver 20 transformative medications that address the most significant societal health challenges 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 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 aligning with cost and quality objectives.
- Partner with Procurement and other key stakeholders, driving the preparation for Requests for Proposals (RFPs) or Statements of Work (SOW), negotiating supply agreements, and selecting vendors for outsourced clinical packaging.
- Support leadership in defining outsourced supply strategies for product supply chains requiring a non-standard design.
- Oversee the budgeting process and submissions for CMO project variable costs.
- Collaborate with upstream functions and leaders to establish team scopes, roles, and responsibilities (e.g., device CMO team). Process ownership for any support models and services provided to other Roche CMO teams.
- Define, track, and report CMO team KPIs, actively driving successful network supply outcomes while 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 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 orders for clinical CMO Packaging in the ERP system.
- Collaborate with internal cross-functional teams to understand needs and expectations for CMO offerings and performance.
- Identify and champion opportunities for internal and external process improvements, applying collaboration skills, technical principles, and expertise to resolve a broad range of supply chain issues.
- Act as the Subject Matter Expert (SME) and primary contact for key initiatives and projects related to CMO Clinical Packaging.
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 equivalent relevant experience.
- PMP/Operational Excellence/Six Sigma/Lean training is desirable.
- 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 apply experience gained from leading teams and/or projects from initiation to delivery.
- High degree of cultural awareness and social competence necessary for successful collaboration with internal and external partners across different cultures and countries.
- Strong analytical and problem-solving skills, coupled with high attention to detail.
- Demonstrated integrity and an ability to instill confidence in colleagues and teams.
- Proven independence in decision-making and priority setting under general leadership direction.
- Ability to leverage cross-functional business expertise to achieve organization-level objectives and address complex problems.
- Excellent communication skills, both written and verbal (proficiency in English; basic German skills are beneficial).
- Effective communicator at all levels, with excellent interpersonal and presentation skills.
- Flexibility to start work early (7 AM for SSF employees) and finish work late (up to 6 PM for Switzerland employees), as well as to work from 10 AM to Noon for Mississauga employees, as needed to accommodate a global environment.
What You Will Be Offered
- An opportunity to work in one of the world's leading pharmaceutical companies.
- A modern campus featuring ample green spaces and meeting areas.
- Centrally located in Basel.
- A diverse job profile with varied responsibilities.
- Further training opportunities through temp training programs.
- The chance to work in a dynamic and motivated team.
If you are interested, please Apply online using the form below. Please note that only applications matching the job profile will be considered.