Associate Director, Process Validation and Risk Management

Vaxcyte, Inc; San Carlos (CA); On-site; USD 174,000 - 203,000; Full time

Benefits offered by this job

Comprehensive benefits

Equity component

Job summary

Vaxcyte, Inc is seeking an Associate Director for Process Validation and Risk Management. This leadership role focuses on ensuring commercial readiness and compliance through strategic process validation and risk management activities across manufacturing processes.

You will collaborate with various teams to facilitate technology transfer and ensure regulatory alignment. The position offers a competitive salary range of $174,000 – $203,000 and is based in San Carlos, CA.

Qualifications

• 9+ years for Ph.D., 11+ years for M.S./M.A., 14+ years for B.S./B.A.
• Experience in biologics/vaccine manufacturing.
• Demonstrated leadership in matrixed environments.

Responsibilities

• Lead and facilitate commercial process validation and risk management.
• Ensure alignment of validation activities with regulatory expectations.
• Collaborate with cross-functional teams for commercialization.

Skills

Process validation

Technology transfer

Quality risk management

Leadership

Problem-solving skills

Communication skills

Data analysis

Strategic planning

Innovative mindset

Education

Ph.D. in relevant discipline

M.S./M.A. in relevant discipline

B.S./B.A. in relevant discipline

Job description

Associate Director, Process Validation and Risk Management

Join our Mission to Protect Humankind!

Vaxcyte is a clinical‑stage vaccine innovation company engineering high‑fidelity vaccines to protect humankind from bacterial diseases that have serious health consequences. We are working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella.

Our work is guided by four core values:

• RETHINK CONVENTION: innovative and diverse thinking to re‑innovate vaccine delivery.
• AIM HIGH: audacious goal to make complex biologics that protect humankind.
• LEAD WITH HEART: inclusive collaboration and vigorous debate.
• MODEL EXCELLENCE: integrity, accountability, equality and clarity in communication and decision making.

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. The role focuses on technical strategy, execution, and cross‑functional coordination to support commercial readiness, regulatory compliance, and lifecycle management.

Essential Functions

Process Validation Leadership

• Provide strategic and scientific leadership for process 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.

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 risk strategies.

Technical Oversight

• Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization.
• Support deviation investigations, ensuring timely resolution and sustained compliance.

Regulatory

• 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.

Raw Material & Network Support

• 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.
• Travel – 10‑30% domestic and international required.

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)
• 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.

Reports to: Senior Director, Process Validation

Location: San Carlos, CA or North Carolina

Compensation

The compensation package is competitive and includes comprehensive benefits and an equity component.

Salary Range: $174,000 – $203,000 (SF Bay Area). Salary ranges for non‑California locations may vary.

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.