Associate Director, Strategic Sourcing and Supplier Management - Medical Devices
Scorpion Therapeutics, California, MO, United States
Role Summary
The Associate Director, Strategic Sourcing & Supplier Management, Medical Devices owns the business relationships with suppliers of devices and device related components used with any Gilead branded product. This includes ownership of the strategy, selection, risk, and performance management of suppliers providing devices and device related components for development or commercial products. This role is responsible for both the strategic and tactical business management of these supplier relationships. You will have responsibility for indirectly leading and influencing others, bidding, selecting and managing multiple devices and device related components. This position is based at the Gilead site in Foster City, CA, and is eligible for the Gilead GFlex program allowing remote work up to 2 days per week.
Responsibilities
Serve as the primary point of contact for business discussions, long range supply and capacity planning, and business development
Management of supplier performance (daily/monthly/annually)
Manage the day to day performance of assigned suppliers and serve as an escalation point for issue resolution for other functional areas and both internal and external manufacturing sites.
Serve as an escalation point for manufacturing operations team members for recurrent or chronic performance issues with supplier.
Lead annual business review meetings (BRMs) with assigned suppliers as needed
Lead the assessment and mitigation of supplier risks through regular supplier risk management processes
Responsible for preparation, reviewing, challenging, and tracking of RFPs/RFQs/RFIs for new business with external suppliers and in consultation with functional stakeholders (Manufacturing Operations, Technical Development, Quality Assurance, Analytical Operations etc.)
Negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
In collaboration with Product and Portfolio Strategy team members, identify and manage strategic suppliers of devices and device related components in alignment with network supply chain strategies
Identify and manage strategic suppliers of direct materials in alignment with approved Category Management Team (CMT) strategies.
Support make vs. buy analysis
Lead and participate in Operational Excellence projects.
Coordinate/lead meetings internally and with suppliers, publishes meeting minutes.
Provide leadership and training to other department personnel
Develop budgets and accurately report accruals to Finance if/as needed
Participates in solving issues of high complexity.
Communicates issues to line manager and project teams in a timely manner
Support product team needs for the selection of suppliers to provide required supplies from development through commercialization.
Lead and/or support site assessment teams (SATs) in the assessment and selection of suppliers
Stay informed and knowledgeable of relevant development and commercial material supplier capabilities, offerings, capacities, etc. as they relate to potential or known Gilead pipeline needs.
Establish quality and technical execution expectations with suppliers
Collaborate and establish regular meetings with key stakeholders and partners to ensure outsourced needs are met
Organize and participate in teleconferences and face-to-face meetings with global suppliers; work closely with Gilead teams to establish agenda and keep track of key decisions
Qualifications
Required:
Basic Qualifications — Bachelor's Degree and Ten Years’ Experience OR Masters' Degree and Eight Years’ Experience OR PhD and Two Years’ Experience
Preferred: 10+ years of experience in a pharmaceutical/biotech organization or relevant manufacturing environment and a BA or BS degree; an MA/MBA degree may be considered as 2 years of relevant experience and Ph.D. may be considered as 4 years’ experience.
Prior experience leading outsourced development and manufacturing service providers and/or direct material suppliers
Experience working with medical devices.
Strong computer skills and experience with an ERP system and project management software
Understanding of activities related to the CMC development of biopharmaceuticals
Advanced knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)
Ability to lead cross functional teams
Strong people management skills
Experience negotiating complex agreements
Strong verbal and written communication skills
Ability to manage multiple programs/projects; sound organizational and time management skills
Ability to develop concise presentations to convey complex issues to senior management
Ability to work under uncertainty and to resolve conflict in a constructive manner
Ability to solve highly complex problems through ingenuity and collaboration with subject matter experts and other key stakeholders
Ability to work in a fast-paced environment
Project management experience and/or certification are a plus
This position may require up to 20% domestic and/or international travel
Education
Bachelor's Degree required; Advanced degrees may be substituted per the qualifications above
Additional Requirements
None beyond the travel expectation noted above
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Responsibilities
Serve as the primary point of contact for business discussions, long range supply and capacity planning, and business development
Management of supplier performance (daily/monthly/annually)
Manage the day to day performance of assigned suppliers and serve as an escalation point for issue resolution for other functional areas and both internal and external manufacturing sites.
Serve as an escalation point for manufacturing operations team members for recurrent or chronic performance issues with supplier.
Lead annual business review meetings (BRMs) with assigned suppliers as needed
Lead the assessment and mitigation of supplier risks through regular supplier risk management processes
Responsible for preparation, reviewing, challenging, and tracking of RFPs/RFQs/RFIs for new business with external suppliers and in consultation with functional stakeholders (Manufacturing Operations, Technical Development, Quality Assurance, Analytical Operations etc.)
Negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
In collaboration with Product and Portfolio Strategy team members, identify and manage strategic suppliers of devices and device related components in alignment with network supply chain strategies
Identify and manage strategic suppliers of direct materials in alignment with approved Category Management Team (CMT) strategies.
Support make vs. buy analysis
Lead and participate in Operational Excellence projects.
Coordinate/lead meetings internally and with suppliers, publishes meeting minutes.
Provide leadership and training to other department personnel
Develop budgets and accurately report accruals to Finance if/as needed
Participates in solving issues of high complexity.
Communicates issues to line manager and project teams in a timely manner
Support product team needs for the selection of suppliers to provide required supplies from development through commercialization.
Lead and/or support site assessment teams (SATs) in the assessment and selection of suppliers
Stay informed and knowledgeable of relevant development and commercial material supplier capabilities, offerings, capacities, etc. as they relate to potential or known Gilead pipeline needs.
Establish quality and technical execution expectations with suppliers
Collaborate and establish regular meetings with key stakeholders and partners to ensure outsourced needs are met
Organize and participate in teleconferences and face-to-face meetings with global suppliers; work closely with Gilead teams to establish agenda and keep track of key decisions
Qualifications
Required:
Basic Qualifications — Bachelor's Degree and Ten Years’ Experience OR Masters' Degree and Eight Years’ Experience OR PhD and Two Years’ Experience
Preferred: 10+ years of experience in a pharmaceutical/biotech organization or relevant manufacturing environment and a BA or BS degree; an MA/MBA degree may be considered as 2 years of relevant experience and Ph.D. may be considered as 4 years’ experience.
Prior experience leading outsourced development and manufacturing service providers and/or direct material suppliers
Experience working with medical devices.
Strong computer skills and experience with an ERP system and project management software
Understanding of activities related to the CMC development of biopharmaceuticals
Advanced knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)
Ability to lead cross functional teams
Strong people management skills
Experience negotiating complex agreements
Strong verbal and written communication skills
Ability to manage multiple programs/projects; sound organizational and time management skills
Ability to develop concise presentations to convey complex issues to senior management
Ability to work under uncertainty and to resolve conflict in a constructive manner
Ability to solve highly complex problems through ingenuity and collaboration with subject matter experts and other key stakeholders
Ability to work in a fast-paced environment
Project management experience and/or certification are a plus
This position may require up to 20% domestic and/or international travel
Education
Bachelor's Degree required; Advanced degrees may be substituted per the qualifications above
Additional Requirements
None beyond the travel expectation noted above
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