Associate Director, Process Validation & Risk Leadership

Vaxcyte; United States; Remote; USD 174,000 - 203,000; Full time

Benefits offered by this job

Comprehensive benefits

Equity component

Job summary

Vaxcyte is seeking an Associate Director, Process Validation and Risk Management to lead validation across commercial manufacturing, guiding technical strategy and cross-functional execution to support readiness, regulatory compliance, and lifecycle management.

Reporting to the Senior Director, Process Validation, you will drive PPQ/CPV programs, risk assessments, tech transfer, and collaborations with Regulatory, Quality, and external CMOs to ensure continuous validated state.

Qualifications

• Degree in chemical or biochemical engineering, chemistry, biochemistry, or related field.
• Experience in biologics/vaccine manufacturing and process validation.
• Knowledge of PPQ/CPV and lifecycle validation concepts.
• Experience with technology transfer and commercialization.
• Familiarity with quality risk management (ICH Q9) and regulatory expectations.
• Strong leadership in matrixed or cross-functional teams.

Responsibilities

• Provide strategic and scientific leadership for process validation across commercial programs.
• Lead validation strategies to support technology transfer, site readiness, and product launch.
• Ensure validation activities align with regulatory expectations and lifecycle plans.
• Develop risk management frameworks and lead cross-functional risk assessments.
• Monitor risk trends and communicate insights to stakeholders.
• Support ongoing mature manufacturing by keeping processes validated and controlled.
• Collaborate with Regulatory, CMC, Quality, Supply Chain, and Engineering.
• Guide validation of processes, systems, facilities, and methods within the organization.
• Contribute to regulatory filings and responses with scientific rationale.

Skills

Process validation leadership

Risk management

MSAT / manufacturing sciences

Technology transfer

Regulatory expectations

Cross-functional leadership

Data-driven decision making

Strategic planning

Education

Ph.D. in Chemical/Biochemical Engineering or related

M.S./M.A. in Chemical/Biochemical Engineering or related

B.S./B.A. in Chemical/Biochemical Engineering or related

Job description

Vaxcyte is seeking an Associate Director, Process Validation and Risk Management to lead validation across commercial manufacturing, guiding technical strategy and cross-functional execution to support readiness, regulatory compliance, and lifecycle management.

Reporting to the Senior Director, Process Validation, you will drive PPQ/CPV programs, risk assessments, tech transfer, and collaborations with Regulatory, Quality, and external CMOs to ensure continuous validated state.