Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte is seeking an experienced candidate to support implementation of our OMP Advanced Planning (APS), SAP Enterprise Resource Planning (ERP) and future Supply Chain systems, as part of our Commercial Manufacturing and Supply Chain (CMSC) organization. This is a business role, not an IT role. It is focused on process definition, systems design, and integration of the Supply Chain Management, Procurement, Logistics, Manufacturing, AD/QC, and Quality business functions at Vaxcyte. The candidate will work closely with the Director, Supply Chain Systems to implement the Plan to Deliver and Direct Procure to Pay workstreams.
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: Support the end-to-end design and implementation of SAP and OMP for the Supply Chain Management, Procurement, Manufacturing, AD/QC and Quality business functions. Develop and align integrated business processes for the above functions, incorporating best practices and industry standards while adhering to compliance standards and regulatory requirements.
* Stakeholder Management: Serve as the primary Vaxcyte Switzerland contact for the OMP and SAP implementation projects. 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: Support the governance of master data for supply chain systems. 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: Lead process and system improvements, enhancements, and upgrades to scale Vaxcyte’s capabilities and integration with our primary Switzerland-based CMO. 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.
* SAP and OMP EU 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:
* S. / B.A. degree or Advanced Degree (preferred).
* 8+ years of experience working in commercial pharmaceutical / biotech companies with a focus on APS/ERP implementations
* Has completed multiple SAP S/4 HANA lifecycle systems implementations in similar roles
* 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 systems 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
Reports to: Director, Supply Chain Europe
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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