Associate Director, QC (Analytical Technical Lead) Global Analytics

Vaxcyte, Inc; San Carlos (CA); On-site; USD 176,000 - 206,000; Full time

Job summary

Vaxcyte, Inc is seeking an Associate Director, QC (Analytical Technical Lead) to drive analytical strategy across Global Analytics. You will coordinate across Development, Process Development, Analytical and Manufacturing Science, QC, Regulatory Affairs, and external partners to ensure compliant, scalable analytical solutions with strong leadership and communication.

The role leads the analytical readiness of programs, drives life-cycle documentation, and supports regulatory submissions in a

Qualifications

• Bachelor degree in analytical or pharmaceutical sciences with 10+ years in vaccine/biopharma.
• Experience in matrixed, cross-functional environments with strategic planning.
• Deep understanding of regulatory data integrity and lifecycle requirements.
• Strong communication, negotiation, leadership and relationship-building.
• Systems-thinking mindset for complex organizational structures.
• Experience with digital tools for data management and collaboration.

Responsibilities

• Champion cross-functional analytical strategies across development, QC, regulatory, and manufacturing.
• Lead integration and harmonization of analytical workflows across sites and partner organizations.
• Ensure alignment of analytical deliverables with program timelines, quality standards, and regulatory milestones.
• Develop and maintain analytical roadmaps and risk registers.
• Contribute to audit readiness and regulatory submissions.

Skills

Analytical Chemistry

Quality Control

Regulatory knowledge

Leadership & collaboration

Data-driven decision making

Education

Bachelor's degree in Analytical Chemistry/Pharmaceutical Sciences

Tools

LIMS

Document management tools

Workflow collaboration tools

Job description

Associate Director, QC (Analytical Technical Lead) Global Analytics

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.

WHAT we do is every bit as important as HOW we 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 Analytical Technical Leader (ATL) is a key strategic role within a matrixed global vaccine organization, responsible for orchestrating analytical activities across diverse functions, teams, and geographic regions. This role ensures end-to-end alignment between Analytical Development, Process Development, Analytical and Manufacturing Science and Technology, Quality Control, Regulatory Affairs, Manufacturing, and external partners including CDMOs and CTOs. Without direct line management, the ATL will leverage their influence, technical expertise, and communication finesse to drive consistency, compliance, and innovation across the analytical landscape.

Essential Functions:

• Champion cross-functional analytical strategies between development, QC, regulatory, and manufacturing.
• Pulls the analytical stages of each project through the product lifecycle ensuring commercial readiness to enable Quality by design from early stage and adapting on the project need per product phase.
• Lead integration and harmonization of analytical workflows across sites and partner organizations.
• Ensure alignment of analytical deliverables with broader program timelines, quality standards, relevant regulations and industry standards as well as regulatory milestones.
• Vaxcyte internal analytical contact for all functional stakeholders.

Operational Oversight

• Accountable for the analytical readiness of the assigned project to meet execution timelines and delivery of the overall program.
• Ensure the scalability, reliability, and regulatory compliance of analytical methods and lifecycle documentation.
• Develop and maintain analytical roadmaps and risk registers supporting critical quality attributes (CQAs).
• Conduit to the analytical steering committee providing updates on analytical stages, outstanding decision, potential risks and proposing mitigations using the ASC for escalation (if needed).
• Communicates analytical updates / decisions / risks within the project governance.
• Provide support for audit readiness and regulatory submissions.

Technical Leadership

• Serve as a thought partner and technical bridge across teams—enabling knowledge transfer and analytical capability building.
• Accountable for the analytical risk register ensuring risks are captured, assessed and tracks status of mitigations.
• Accountable for the process-control-strategy and specifications.
• Review and approval of analytical documents related to the overall analytical strategy.

Leadership & Influence

• Drive decision-making and consensus through strong communication, stakeholder management, and systems thinking.
• Contribute to workforce planning, capability road‑mapping, and organizational development for global analytical teams.

Requirements:

• Bachelor degree in Analytical Chemistry, Pharmaceutical Sciences, or related field. 10+ years of experience in vaccine or biopharmaceutical industry with strong background in Quality Control or related analytical disciplines. Other combinations of education and/or experience may be considered.
• Proven success in matrixed environments with cross-functional coordination and strategic planning.
• Deep understanding of regulatory frameworks, data integrity, and method lifecycle requirements.
• Exceptional communication, negotiation, leadership and relationship-building.
• Systems‑thinking mindset and ability to identify leverage points in complex organizational structures.
• Experience with digital tools for data management, document review workflows, and collaborative project planning.
• Passion for mentoring, alignment building, and growing global technical communities.
• Strong analytical and problem‑solving abilities, with a focus on data‑driven decision‑making and continuous improvement.
• Level of Supervision: General Supervision.
• The role will perform a variety of routine work within established policies and procedures. It is expected that the role receives rather high‑level project information instead of detailed instructions on a weekly basis and general instructions on new projects and assignments.

Reports to: Senior Director, Quality Control

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

Hybrid

Compensation:

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

Salary Range: $176,000 - $206,000 (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.