Essential Functions:

• Project Management:  Partner with project managers to develop detailed project plans. Coordinate and lead cross functional teams to ensure successful project execution per the project plans.  Monitor progress, manage schedule, issues and risks, and provide status updates.
• APS and ERP Design and Implementation:  Oversee the end-to end design and implementation for the Supply Chain Management, Procurement, Manufacturing, AD/QC and Quality business functions. Develop and align integrated business processes with APS and ERP solutions, incorporating best practices and industry standards while adhering to compliance standards and regulatory requirements.
• Stakeholder Management: Serve as the primary CSMC business contact for APS and ERP. Communicate effectively with all internal and external stakeholders and project team members including business partners, software vendors, and integrators.  Facilitate team meetings to keep stakeholders engaged and informed. Escalate appropriately to senior management for awareness and decision making.
• Resource Management: Identify resources and skills necessary to complete project activities and meet project goals.  Coordinate with department managers to secure necessary resources and support.  Monitor resource allocation and develop contingency plans to address resource constraints.
• Business Training and Support: Develop and deliver training programs to ensure end user adoption of business processes and systems.  Develop and maintain training documentation including policies, standard operation procedures (SOPs), and work instructions. 
• Performance Management and Optimization: Work with global process owners and key stakeholders to align key performance indicators (KPIs). Monitor performance, analyze data, and identify areas for optimization. Drive continuous improvement through iterative enhancements.
• Master Data Management: Lead the management and governance of master data for supply chain systems.  Establish data standards and definitions.  Lead the creation, maintenance and quality control of master data.  Ensure data is aligned with business needs and meets regulatory requirements.  Design and implement the data management end-to-end process and data quality and accuracy KPIs.
• Process and systems continuous improvement: In collaboration with IT, define the systems roadmap tied to business objectives and needs.  Define and lead process and system improvements, enhancements, and upgrades to scale Vaxcyte’s capabilities. Secure business resources to support initiatives. Ensure end-user support and troubleshooting are provided post implementation and verify new functionalities are properly rolled out and intended benefits are achieved.
• ERP and APS Business Systems Owner: Ensure systems are maintained in compliance with changing and/or new regulatory and validation requirements.  With IT, maintain validation documentation and ensure the systems operate in a state of control.  Work closely with quality assurance to comply with industry standards and regulatory guidelines.

Requirements:

• B.S. / B.A. degree or Advanced Degree (preferred).
• 12+ years of experience working in commercial pharmaceutical / biotech companies with a focus on APS/ERP implementations.
• Proficient the APS systems (e.g. Kinaxis, OMP, O9) and ERP systems (Oracle, SAP, Microsoft Dynamics).
• PMP or similar project management certification and proficient in project management tools (e.g. MS Project and Smartsheet).
• Strong experience working with CMOs, Software Vendors and Integrators.
• In-depth knowledge of GMPs, FDA regulations and biotech industry standards.
• Strong experience leading cross-functional teams.
• Proficient in change management methodologies (e.g. Prosci ADKAR, Kotter’s Change Model) or demonstrated experience in leading change management initiatives.
• Design and implementation expertise in APS and ERP systems with a proven track record of managing and delivering fast-track projects successfully.
• Comprehensive knowledge of Supply Chain, Procurement, Manufacturing, Quality and Regulatory processes.
• Experience with system validation processes, including developing and executing validation plans to ensure compliance with regulatory requirements.
• Experience with Lean, Six-Sigma or other process improvement methodologies.
• Strong communication, problem-solving, analytical and decision-making skills.