Job FunctionsFDA Inspection Readiness & Regulatory ComplianceAudit Program ManagementQuality Systems & Compliance Oversight
Job RequirementsBachelor's degree 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 industryExtensive experience in FDA inspection management, internal audits, and third-party audits.ASQ certification (CQA, CQE) or auditor certification preferred.
SkillsStrong 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.RETHINK CONVENTION: Creative and intellectual diversityAIM HIGH: Courageous goal-setterLEAD WITH HEART: Kindness-first approach to collaboration and vigorous debate
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:
Vaxcyteis 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 ComplianceLocation: San Carlos, CACompensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.Salary Range: $184,000 – $218,000 (SF Bay Area). Salary ranges for non-California locations may vary.Vaxcyte, Inc. 825 Industrial Road, Suite 300San Carlos, CA 94070We 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.Apply for this job
Life at Vaxcyte
Thrive Here & What We ValueCourageously make the most complex biologics ever attempted to protect humankind | Model excellence with a shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | Models our Core Values: is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.</s> | Rethink convention | Aim high | Lead with heart | Model excellence</s> | Vaxcyte is committed to protecting humankind from bacterial diseases through high-fidelity vaccines. | The company values creativity and intellectual diversity in all aspects of its work. | Vaxcyte aims to make the most complex biologics ever attempted to protect humankind. | The company leads with kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives. | Vaxcyte models excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision-making.</s> | 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.</s> | AIM HIGH: Embody 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 business objectives. | RETHINK CONVENTION: Bring creative and intellectual diversity to every facet of work done in order to innovate and re-innovate the way vaccines are delivered. | MODEL EXCELLENCE: Demonstrate integrity, accountability, equality and clarity across communications and decision making.</s> | AIM HIGH: Courageously make the most complex biologics ever attempted to protect humankind. | LEAD WITH HEART: Kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives. | RETHINK CONVENTION: Creative and intellectual diversity to every facet of work done in order to innovate and re-innovate the way vaccines are delivered. | MODEL EXCELLENCE: Shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | Collaborative role working closely with the Supply Chain team to deliver a system that will support Vaxcyte's growth through commercialization. | Promote a culture of continuous improvement by identifying areas for enhancement and implementing best practices in SAP and APS program management.</s> | Shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making</s> | Kindness-first approach to collaboration and vigorous debate that advances business objectives | Vaxcyte's mission is to protect humankind from bacterial diseases, which have serious and costly health consequences when left unchecked. | The company values rethinking convention, aiming high, leading with heart, and modeling excellence in their work. | They prioritize collaboration across teams and strive for process improvement initiatives to enhance efficiency and compliance.</s> | 1. RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and reinnovate the way vaccines are delivered | 2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind | 3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindnessfirst, inclusive approach to collaboration and vigorous debate that advances our business objectives | 4. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making</s> | Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases | Our work together is guided by four enduring core values: RETHINK CONVENTION, AIM HIGH, LEAD WITH HEART, and MODEL EXCELLENCE | 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.</s> | Bringing creative and intellectual diversity to every facet of the work done in order to innovate and re-innovate the way vaccines are delivered</s> | Join our mission to protect humankind from the consequences of bacterial diseases | Collaborate with various stakeholders to understand integration requirements and translate them into technical solutions | Stay up to date with the latest trends and technologies in integration, particularly within the Workato ecosystem | Participate in code reviews and ensure the quality of integration solutions | Proactively identify and address potential integration challenges | Manage and prioritize integration projects, ensuring timely delivery and within budget</s> | Shared commitment to demonstrating integrity, accountability, equality, and clarity across communications and decision making | 11. RETHINK CONVENTION: Creative and intellectual diversity in every aspect of work | 12. AIM HIGH: Courageously make the most complex biologics ever attempted to protect humankind | 13. LEAD WITH HEART: Kindnessfirst, inclusive approach to collaboration and vigorous debate that advances business objectives | 14. MODEL EXCELLENCE: Shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | The company leads with a kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives. | The company models excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision-making.</s> | Collaborative and high-performance project team environment. | Aim high by embodying our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. | Model excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision making. | Lead with heart by everyone leading at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</s> | 4. MODEL EXCELLENCE: Shared Commitment to Demonstrating Integrity, Accountability, Equality and Clarity Across Communications and Decision Making</s> | Courageous goal to make the most complex biologics ever attempted to protect humankind | Bringing creative and intellectual diversity to every facet of work to innovate and re-innovate the way vaccines are delivered</s> | Shared Commitment to Demonstrating Integrity, Accountability, Equality, and Clarity Across Communications and Decision Making</s> | Mission-driven: working towards protecting humankind from the consequences of bacterial diseases | Collaborative: guided by four enduring core values that prioritize collaboration and inclusion | Innovative: bringing creative and intellectual diversity to every facet of work to innovate and re-innovate the way vaccines are delivered | Ambitious: embodying a collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</s> | Mission to protect humankind from bacterial diseases | Collaborative work environment guided by four core values: Rethink Convention, Aim High, Lead With Heart, Model Excellence | Commitment to scientific excellence, innovation, and integrity within the medical and clinical affairs team.</s> | Vaxcyte values creativity and intellectual diversity to innovate and re-innovate the way vaccines are delivered. | They aim high and embody their collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. | They lead with heart, everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances their business objectives. | They model excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision making.</s> | Rethink convention: bring creative and intellectual diversity to every facet of the work done in order to innovate and re-innovate the way vaccines are delivered | Caring: Vaxcyte is committed to protecting humankind from the consequences of bacterial diseases | Courage: Vaxcyte embodies a collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind | Excellence: Vaxcyte strives for world-class finance organization that is customer service-oriented and highly accountable | Passion: Vaxcyte's cultural attributes include caring, courage, excellence, and passion</s> | Kindness-first and inclusive approach to collaboration and vigorous debate that advances 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.</s> | Kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives</s> | 1. RETHINK CONVENTION: Creative and Intellectual Diversity to Innovate and ReInnovate the Way Vaccines are Delivered | 2. AIM HIGH: Embodiment of Collectively Audacious Goal to Courageously Make the Most Complex Biologics Ever Attempted to Protect Humankind | 4. MODEL EXCELLENCE: Shared Commitment to Demonstrating Integrity, Accountability, Equality, and Clarity Across Communications and Decision Making</s> | Collaborative culture | Continuous improvement mindset | Kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives.</s> | 1. RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and reinnovate the way vaccines are delivered. | 2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. | 3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindnessfirst, inclusive approach to collaboration and vigorous debate that advances our business objectives. | 4. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | Commitment to protecting humankind from bacterial diseases | Emphasis on continuous improvement and risk mitigation strategies | Rethink Convention: Bring creative and intellectual diversity to every facet of work to innovate and re-innovate the way vaccines are delivered. | Model Excellence: Shared commitment to demonstrating integrity, accountability, equality, and clarity across communications and decision making.</s> | Vaxcyte values creativity and intellectual diversity in every facet of the work they do | They model excellence by demonstrating integrity, accountability, equality and clarity across communications and decision making.</s>
