Role Summary
The Associate Director, Strategic Sourcing & Supplier Management, Commercial Packaging owns the business relationship with one or more contract development and manufacturing organizations (CDMOs) and/or direct material suppliers. This includes ownership of the strategy, selection, risk, and performance management of CDMOs providing primary and/or secondary packaging services for commercial products. This role is responsible for the strategic management of these CDMO packaging relationships, requiring a high-energy, results-driven approach to drive performance from partners. Based at the Gilead site in Foster City, CA, with eligibility for remote work up to 2 days per week through the GFlex program.
Responsibilities
- Serve as the primary point of contact for business discussions, long range supply and capacity planning, and business development
- Management of supplier performance (monthly/annually)
- Serve as an escalation point for manufacturing operations team members for recurrent or chronic performance issues with suppliers
- Lead annual business review meetings (BRMs) with assigned CDMOs 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
- Negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
- Identify and manage strategic suppliers of Commercial Packaging in alignment with network supply chain strategies
- Support make vs. buy analysis
- Lead and participate in Operational Excellence projects
- Coordinate/lead meetings internally and with CMO’s, publish 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 external service and/or material suppliers to provide required services and/or supplies from development through commercialization
- Lead and/or support site assessment teams (SATs) in the assessment and selection of suppliers
- Stay informed 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 track key decisions
Qualifications
- Required: 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; leadership of outsourced development and manufacturing service providers and/or direct material suppliers
- Preferred: Strong computer skills and experience with an ERP system and project management software
- Preferred: Understanding of activities related to the CMC development of biopharmaceuticals
- Preferred: Advanced knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)
- Preferred: Ability to lead cross functional teams
- Preferred: Strong people management skills
- Preferred: Experience negotiating complex agreements
- Preferred: Strong verbal and written communication skills
- Preferred: Ability to manage multiple programs/projects; sound organizational and time management skills
- Preferred: Ability to develop concise presentations to convey complex issues to senior management
- Preferred: Ability to work under uncertainty and to resolve conflict in a constructive manner
- Preferred: Ability to solve highly complex problems through ingenuity and collaboration with subject matter experts and other key stakeholders
- Preferred: Ability to work in a fast-paced environment
- Preferred: Project management experience and/or certification is a plus
- Preferred: Up to 20% domestic and/or international travel
Skills
- Strategic relationship management with CDMOs and direct material suppliers
- Vendor risk assessment and mitigation
- RFP/RFQ/RFI process management and negotiations
- Budget development and accrual reporting
- Cross-functional collaboration and stakeholder management
- ERP and project management software proficiency
- Strong written and verbal communication
Education
- Bachelor’s Degree required; advanced degrees preferred (Masters or PhD)
Additional Requirements
- Up to 20% travel (domestic and/or international)