Associate Director, Process Validation

Summary:

The Associate Director, Process Validation and Risk Management will lead and facilitate commercial process validation and risk management activities across Vaxcyte’s end-to-end manufacturing processes. This role focuses on technical strategy, execution, and cross-functional coordination to support commercial readiness, regulatory compliance, and lifecycle management.

The incumbent will provide leadership to ensure the organization is equipped to effectively design, execute, and communicate process validation and risk management strategies to internal stakeholders, external partners, and regulatory agencies.

This position will report to the Sr. Director of Process Validation within the Global MSAT organization and will collaborate on overall validation strategy, with primary responsibility for process validation execution and risk management frameworks supporting commercial manufacturing.

Essential Functions:

Process Validation Leadership

• Provide strategic and scientific leadership for process validation (PPQ, CPV, lifecycle validation) across commercial programs.
• Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch.
• Ensure alignment of validation activities with regulatory expectations and lifecycle management plans.

Risk Management

• Develop and implement risk management frameworks, tools, and processes in collaboration with Quality.
• Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks.
• Monitor and communicate risk trends and key risk indicators to stakeholders.

Commercialization & Lifecycle Support

• Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state.
• Contribute to lifecycle management activities, including process improvements and continued process verification.

Cross-functional Interface

• Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity.
• Partner with internal teams and external CMOs to ensure alignment on validation and