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Associate Director, Quality Assurance and Compliance
San Carlos, California, United States
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, periodontitis 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:
Vaxcyte is seeking an Associate Director, Quality Assurance & Compliance to lead FDA inspection readiness efforts, oversee internal and third-party audit programs, and ensure compliance with regulatory requirements and industry best practices. This role will be instrumental in developing and maintaining a robust Quality Management System (QMS) to support GxP operations, collaborating cross-functionally to drive quality culture and continuous improvement.
Essential Functions:
- FDA Inspection Readiness & Regulatory Compliance
- Develop and implement FDA inspection readiness strategies, ensuring the site and personnel are well-prepared for regulatory interactions.
- Lead cross-functional inspection readiness activities, including mock inspections, training, and CAPA follow-ups.
- Routinely interface with cross-functional teams (clinical, QC, manufacturing, etc.) to report quality and inspection readiness metrics to management.
- Support the primary liaison for FDA and other regulatory agency inspections, ensuring timely responses and resolution of observations.
- Maintain a deep understanding of FDA, ICH, and other global regulatory requirements to ensure compliance across quality systems.
- Audit Program Management
- Develop, manage, and execute internal audit programs to assess compliance with GxP regulations and company policies.
- Oversee receiving third-party audits, including notified bodies, vendor and contract manufacturing organization (CMO) audits, ensuring compliance with quality agreements and regulatory expectations.
- Lead audit observations response and CAPA implementation, ensuring timely closure and effectiveness verification.
- Drive a culture of continuous improvement by analyzing audit trends and implementing proactive risk mitigation strategies.
- Quality Systems & Compliance Oversight
- Ensure the effectiveness and continuous improvement of Audit and Inspection Readiness Quality Management System (QMS) processes, including document control, training, CAPA, deviations, and change control.
- Partner with cross-functional teams to implement risk-based quality oversight for manufacturing, testing, and clinical operations.
- Lead quality training programs to enhance compliance awareness and readiness across the organization.
- Provide strategic guidance on compliance trends and emerging regulatory expectations to senior leadership.
Requirements:
- Bachelors in a scientific discipline (e.g., Biology, Chemistry, Engineering, or related field).
- 10+ years of experience in Quality Assurance, Compliance, or Regulatory Affairs in the biopharmaceutical or vaccine industry.
- Extensive experience in FDA inspection management, internal audits, and third-party audits.
- Strong knowledge of GMP, GLP, and GCP regulations, as well as ICH guidelines and global regulatory expectations.
- Proven ability to work cross-functionally and lead teams in a fast-paced, regulated environment.
- Excellent communication skills with the ability to interface with regulatory agencies, executive leadership, and external partners.
- ASQ certification (CQA, CQE) or auditor certification preferred.
Reports to: Senior Director, Quality Assurance and Compliance
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $184,000 - $214,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Relocation:
This role is not eligible for relocation assistance.
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.
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