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 met .
• Partner with Procurement and other key stakeholders and drive the preparation for Requests for Proposal (RFPs) or Statements of Work (SOW), negotiate supply agreements and select vendors for outsourced clinical packaging.
• Actively 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 and leaders to establish team scope and division of roles and responsibilities (e.g. device CMO team). Process ownership for any support models and service provision to other Roche CMO teams .
• 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 .
• Partner with CMOs to ensure capability and capacity 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 of CMO invoices.
• Perform pre and post-production order management for clinical CMO Packaging orders in the ERP system .
• Collaborate with internal cross-functional teams to understand needs/expectations for CMO offerings and performance.
• Identify and champion internal and external process improvement opportunities and apply collaboration skills, technical principles and expert knowledge to drive solutions to a broad range supply chain issues.
• Represent CMO Clinical Packaging as SME and primary contact on key initiatives and projects. Job Requirements
Must Haves:
• 8+ years in the pharma industry, supply chain management or in manufacturing (*****)
• Experience with clinical drug manufacturing or clinical supply chain or contract manufacturing management strongly preferred (*****)
• Proficient knowledge and experience of SAP or ERP system (*****)
• BA/BS Degree, preferably in a technical, business or supply chain field. Masters Degree a plus .
• APICS and/or SCOR certification, or equivalent relevant experience (*****)
• PMP/Operational Excellence/Six Sigma/Lean training a plus
• 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 as required for successful internal/external collaboration and communications with external partners from different cultures and countries.
• Strong analytical and problem solving skills, high attention to detail, and understanding of systems.
• Demonstrated track record of integrity and ability to instill confidence in colleagues and teams.
• Demonstrated ability to operate independently and set priorities under general leadership direction.
• Proven track record of self-reliance in making sound decisions and accountability for decisions taken.
Ability to apply cross-functional business expertise towards achievement of organization-level objectives and to address complex problems .
• Ability to communicate clearly and professionally both in writing and verbally (Excellent English skills - German basic skills beneficial) .
• Effective communicator at all levels; excellent written, oral and interpersonal communications and presentation skills.
• Flexibility to start work as early at 7am (SSF employees), finish work as late as 6pm (Switzerland employees) and to work from 10am-Noon (Mississauga employees), as needed to meet needs of global environment
• CVs have to be uploaded in English.
