Assoicate Director, Process Validation

Vaxcyte•San Carlos, CA

4d•$174,000 - $203,000•Hybrid

About The Position

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.

Requirements

Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A.
Strong experience in biologics/vaccine manufacturing, including: Process validation (PPQ/CPV), MSAT, technical operations, or late-stage development, Technology transfer and commercialization
Experience in quality risk management (ICH Q9) and regulatory expectations
Demonstrated leadership in matrixed or cross-functional team environments
Ability to apply deep technical knowledge to develop strategies and drive execution
Strong problem-solving, organizational, and strategic planning skills
Excellent communication and stakeholder engagement skills
Ability to analyze data and align stakeholders with organizational strategy
Innovative and entrepreneurial mindset to drive continuous improvement
An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Responsibilities

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.
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.
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.
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 risk strategies.
Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization.
Support deviation investigations, ensuring timely resolution and sustained compliance.
Contribute to authoring and reviewing regulatory filings and responses to health authorities.
Effectively communicate the scientific and commercial rationale for validation and risk management strategies.
Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance.
Provide guidance on raw material qualification strategies to ensure supply reliability.
Support validation activities across internal and external manufacturing networks.
Communicate process validation performance and risk insights to key stakeholders.
Build strong working relationships and influence across a matrixed organization.
Contribute as a key member of the Global MSAT organization to enable successful commercialization.