Executive Director Quality Assurance, External Manufacturing

Regulatory Jobs; San Carlos (CA); Hybrid; USD 300,000 - 350,000; Full time

Benefits offered by this job

Equity component

Comprehensive benefits

Hybrid work model

Job summary

Vaxcyte is seeking an Executive Director, Quality Assurance, External Manufacturing to lead the QA function across a global CDMO network and drive the quality strategy for outsourced operations. The role ensures GMP compliance, product quality, and regulatory readiness while enabling supply continuity and timely product release.

This leader will foster strategic partnerships, govern risk-based quality oversight, and guide cross-functional teams across Technical Operations, CMC, Regulatory, and

Qualifications

• Minimum 16 years in Quality Assurance within biopharmaceuticals, with strong external manufacturing leadership.
• Extensive GMP/FDA regulatory expertise and ICH knowledge.
• Proven track record leading complex external QA networks without direct authority.

Responsibilities

• Own external quality performance across the CDMO network, ensuring compliance and supply continuity.
• Provide end-to-end QA leadership for GxP activities, including release of drug substances/products.
• Represent Quality in cross-functional/executive forums and influence key decisions.
• Establish governance with external partners and drive continuous improvement.
• Drive inspections readiness and support PAIs and regulatory inspections.

Skills

GMP knowledge

FDA regulations

CDMO oversight

External QA

Leadership

Risk management

Process validation

Technology transfer

Inspection readiness

Executive communication

Education

BS/BA degree

Job description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHATwe do is every bit as important asHOWwe 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:

The Executive Director, Quality Assurance, External Manufacturing is responsible for leading the External Manufacturing Quality function and executing the quality strategy across Vaxcyte’s global network of Contract Development and Manufacturing Organizations (CDMOs) and external partners. In a highly outsourced operating model, this role ensures that externally executed GMP activities are compliant with global regulatory requirements and Vaxcyte quality standards, supporting product quality, supply continuity, and regulatory readiness.

This leader drives a proactive, risk-based quality approach and implements scalable systems, governance, and partnerships to enable operational excellence across the external network, supporting clinical development, BLA readiness, and commercial supply. The Executive Director owns external quality performance and operational decision-making within the function, while escalating critical risks and aligning with VP-level strategy. This role requires strong cross-functional leadership and the ability to influence internal and external stakeholders in a highly matrixed environment.

Essential Functions:

• Own quality performance across the external network, ensuring compliance, supply continuity, and effective management of quality risk, with escalation of critical risks to VP-level as appropriate.
• Provide end-to-end QA leadership for externally executed GxP activities, including manufacturing and release of drug substance, drug product, components, and critical raw materials.
• Serve as the senior QA leader for external operations, representing Quality in cross-functional and executive forums, and influencing decisions across Technical Operations, CMC, Regulatory, and Supply Chain.
• Establish and maintain strategic partnerships with external partners, driving accountability, performance management, and continuous improvement.
• Lead quality governance across the external network, including KPIs, escalation pathways, and risk-based oversight models focused on critical processes and high-risk partners.
• Oversee and drive resolution of complex, cross-organizational quality issues, ensuring robust investigations, root cause analysis, and sustainable CAPAs.
• Provide oversight and decision authority for batch disposition and product release, ensuring timely, compliant supply of clinical and commercial materials.
• Drive inspection readiness across the external network, including PAI and global health authority inspections, and serve as a key QA representative during inspections.
• Provide strategic QA leadership for technology transfer, process validation, and lifecycle management across external sites.
• Build, lead, and develop a high-performing External Quality organization, including talent development, succession planning, and organizational scalability.
• Champion a strong quality culture across internal teams and external partners, reinforcing accountability, transparency, and continuous improvement.

Requirements:

BS/BA required, with a minimum of 16 years of progressive experience in Quality Assurance within biopharmaceuticals, including significant leadership in external manufacturing and CDMO oversight, vaccines experience desirable. Other combinations of education and/or experience may be considered.

• Deep expertise in GMP regulations, FDA and global regulatory expectations, and ICH guidelines
• Extensive experience operating within a highly outsourced/CDMO-based manufacturing model
• Proven track record of leading complex external quality networks, driving performance and outcomes without direct authority
• Strong experience supporting technology transfer, process validation, and lifecycle management across multiple external sites
• Demonstrated success in inspection readiness and regulatory inspections, including pre-approval inspections (PAIs)
• Experience establishing governance frameworks, and performance metrics for external partners
• Strong background in risk management and quality systems, with the ability to apply risk-based decision-making in a GxP environment
• Proven ability to influence at the executive level, driving alignment across cross-functional teams and external partners
• Demonstrated experience building, leading, and scaling high-performing teams in a complex, fast-paced environment
• Strong business acumen, with the ability to balance quality, compliance, and supply continuity to support clinical and commercial objectives

Key Competencies

• Strategic Leadership in Outsourced Models
• External Partner Governance & Influence
• Risk-Based Quality Oversight
• Regulatory Inspection Readiness (PAI Focus)
• Executive Communication & Cross-Functional Leadership
• Complex Problem Solving & Decision-Making
• Organizational Development & Talent Leadership

Reports to: Vice President, Quality Assurance

Location: San Carlos, CA

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):

Hybrid (minimum of 3 days per week onsite)

Compensation:

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

Salary Range: $300,000 - $350,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Relocation:

This role is not eligible for relocation assistance.

Equal Opportunity

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.