The Global Head of CMO Clinical Packaging will be responsible for full oversight of outsourced clinical packaging for the Roche Clinical Supply portfolio. Leading a team of 4-6 CMO Site Managers based in both South San Francisco and Kaiseraugst, Switzerland, the individual will be fully responsible for employee management as well as ownership of the outsourcing business processes and contract manufacturer performance. Key responsibilities of the team include setting outsourcing strategy; vendor selection, contracting and negotiation; supplier relationship management (SRM); outsourced supply setup coordination; and production execution oversight.
Lead a global team of CMO Site Managers responsible for implementation and management of clinical contract manufacturing organizations (CMOs) that are needed to meet clinical supply requirements, including primary packaging, syringe/device assembly, clinical labeling and secondary packaging.
Continuously monitor outsourcing market dynamics, maintain industry collaborations, and monitor vendor capabilities with an eye towards innovation.
Lead collaboration with cross-functional teams of subject matter experts to achieve business, operations, and quality objectives at CMOs.
Set and monitor performance goals for the contract manufacturing or business partnerships.
Develop solutions to complex clinical packaging challenges with inter-organizational impact.
Establish and maintain alignment between Genentech/Roche’s goals and objectives and CMOs.
Support development and continuous improvement with CMOs/partners.
Proactively identify and/or assess CMO risks and create strategies to avoid or minimize their impact. Manage the execution of risk mitigation plans.
Establish strong partner relationships with internal stakeholders (External QA, Procurement, Device Development, Technical Development Teams, and Collaborations team) to enable successful planning and implementation plans of clinical activities at CMOs.
Establish strong partnership with both clinical study (CDSL) and network (MPP) Planning teams to determine production requirements and evaluate future needs of clinical programs. Align vendor capacity availability and capabilities within the clinical demand & operations planning (CD&OP) cycle.
Set performance goals for staff as well as establish departmental strategy and objectives, in alignment with the strategy for Global Clinical Supply
Manage competing priorities and allocate, adjust, and optimize assigned department resources.
Identify, design, and implement process and system improvements.
B.S. or B.A. degree with 12+ years of work experience in the pharmaceutical manufacturing or supply chain industry or Master’s Degree with 10+ years of relevant experience
Minimum of 5 years of management experience, ideally in a global setting
Requires strong interpersonal, communication, customer service, organizational and prioritization skills
Successful demonstration of leadership, teamwork, problem solving, decision making and technical skills
Working knowledge of Operational Excellence tools (ie. 5S, Visual Factor, TPM, DMAIC, etc.) required. Green Belt and/or ASCM/APICS certifications preferred.
Broad understanding of ERP (e.g., SAP) systems, including production planning, detailed scheduling, master data and manufacturing execution.
Ability to lead cross-functional, multi-location global projects
Up to 10-20% domestic and international travel
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