Summary:

The Manager, Quality Assurance, External Manufacturing is responsible for overseeing quality activities at contract manufacturing organizations (CMOs), ensuring compliance with cGMP standards, and driving performance through KPIs and continuous improvement initiatives. This role leads batch disposition, reviews critical GMP documentation, supports PPQ activities, and collaborates cross-functionally to resolve complex manufacturing and quality issues. The position requires strong expertise in pharmaceutical quality systems, regulatory requirements, and risk management, along with leadership, problem-solving, and communication skills to support both clinical and commercial operations.

Essential Functions:

• Provide Quality Assurance oversight of Contract Manufacturing Organizations (CMOs).
• Develop and report metrics and key performance indicators (KPIs) to evaluate CMO performance.
• Represent Quality Assurance at internal cross-functional meetings and Joint Project Team meetings.
• Lead polysaccharide batch disposition activities, including review of executed batch records, environmental monitoring data, and quality control results.
• Review and approve GMP documentation, including master batch records, deviations, risk assessments, change controls, and CAPAs.
• Drive resolution of quality performance issues in collaboration with contract manufacturers.
• Support Process Performance Qualification (PPQ) activities.
• Develop, implement, and maintain quality procedures, policies, and standards.
• Collaborate with key stakeholders to develop solutions to complex manufacturing and quality issues.
• Participate in compliance audits and regulatory inspections, as required.
• Promote a strong quality mindset and a culture of quality excellence across all activities.

Requirements: 

• Bachelor’s degree in chemistry, Biology, Pharmacy, Engineering, or a related scientific discipline.
• Minimum 5 years of experience in managing CMO quality, and quality systems management within the pharmaceutical, biotechnology, or life sciences industry. Other combinations of education and experience may be considered.
• Experience in batch record review, deviations and Out of Specification (OOS) investigations.
• Thorough knowledge of cGMP, ICH guidelines, FDA/EMA, Swiss medic regulations, and international pharmaceutical quality standards.
• Experience applying Quality Risk Management principles.
• Experience supporting both clinical and commercial products preferred.
• Strong leadership, management, and process improvement skills.
• Excellent organizational skills with strong attention to detail.
• In-depth understanding of biologics manufacturing operations.
• Proven ability to prioritize multiple assignments in a fast-paced, changing environment.
• Strong problem-solving abilities, including managing complex investigations and root cause analyses.
• Excellent written and verbal communication skills, with the ability to clearly present quality topics and risk-based decisions to cross-functional teams.

Summary:

Vaxcyte is seeking a Manager, QMS Vendor Management & Supplier Notifications to support the effective management of supplier-related quality activities within the Quality Management System (QMS). This role will be responsible for the intake, triage, and coordination of supplier notifications within Veeva QMS, ensuring timely impact assessments and appropriate follow-up actions. The individual will partner cross-functionally to assess risk, drive change controls, and maintain supplier compliance. This role will also contribute to vendor qualification activities, supplier management processes, and may support internal and external audit activities as needed.

Essential Functions:

• Supplier Notification Management
  • Manage the end-to-end lifecycle of supplier notifications within Veeva QMS, including intake, triage, prioritization, and tracking.
  • Perform initial assessments of supplier notifications to determine required actions and level of impact.
  • Assign and coordinate impact assessments with cross-functional stakeholders (e.g., Quality, Regulatory, Manufacturing, Supply Chain).
  • Ensure timely closure of supplier notifications in alignment with internal procedures and regulatory expectations.
  • Maintain visibility of notification status, risks, and trends, escalating issues as appropriate.
• Impact Assessments & Action Management
  • Facilitate and track impact assessments to evaluate potential effects on product quality, regulatory filings, and supply continuity.
  • Coordinate and manage follow-up actions, including change controls, supplier communications, and documentation updates.
  • Ensure actions are completed in a timely manner and in compliance with QMS requirements.
  • Support risk-based decision making and documentation aligned with GxP expectations.
• Vendor Management & Qualification
  • Support vendor qualification and requalification activities, including risk assessments and documentation review.
  • Maintain supplier records and ensure compliance with approved supplier lists and quality agreements.
  • Partner with cross-functional teams to ensure suppliers meet Vaxcyte quality and compliance standards.
  • Assist in maintaining supplier performance metrics and supporting supplier oversight activities.
• Audit Support
  • Participate in internal and external audits, including supplier audits, as needed.
  • Support audit preparation activities and contribute to responses and CAPA development for audit observations.
  • Assist in tracking and closure of audit-related actions.

Requirements: 

• BA or BS in a scientific or related field.
• Minimum of 5 years of experience in Quality Assurance, Supplier Quality, or Vendor Management within the biopharmaceutical, vaccine, or regulated industry. Other combinations of education and/or experience may be considered.
• Experience working within a Quality Management System (QMS), preferably Veeva QMS.
• Strong understanding of GxP regulations (GMP, GLP, GCP) and supplier quality requirements.
• Experience with supplier notifications, change control, and impact assessments preferred.
• Familiarity with vendor qualification and audit processes.
• Strong organizational and project management skills with the ability to manage multiple priorities.
• Excellent communication and cross-functional collaboration skills.
• Detail-oriented with strong problem-solving and risk assessment capabilities.
• ASQ certification (CQA, CQE) or auditor certification preferred.

Summary:

The Director, Quality Assurance – Vendor Management is responsible for executing the global vendor quality strategy to ensure compliance, scalability, and inspection readiness across Vaxcyte’s GxP supplier network. This role provides leadership and oversight of vendor qualification, audit, supplier notifications, and performance management programs, ensuring alignment with corporate objectives and regulatory expectations.

The Director will serve as a key quality leader, influencing cross-functional stakeholders and external partners, while driving continuous improvement, risk-based decision-making, and operational excellence across the vendor ecosystem.

Essential Functions:

• Strategic Leadership & Program Ownership
  • Own and define the global Vendor Management Quality Program, ensuring scalability to support clinical and commercial operations.
  • Provide end-to-end oversight of vendor qualification, auditing, monitoring, and lifecycle management programs.
  • Establish and drive risk-based frameworks for supplier selection, qualification, and oversight aligned with regulatory expectations.
  • Serve as the QA lead for external partnerships, including CMOs, CROs, and critical service providers.
• Audit & Inspection Readiness
  • Oversee the global supplier audit program including preparation, scheduling, performance and audit closeout.
  • Ensure inspection readiness across the vendor network and support regulatory inspections as a QA subject matter expert.
  • Review and approve audit strategies, reports, and CAPA effectiveness, ensuring timely closure and systemic improvement.
  • Plan, schedule, and conduct supplier audits (on-site and remote) in support of supplier qualification and ongoing oversight programs.
• Quality Systems & Governance
  • Provide strategic direction and oversight for Quality Agreements, working closely with the Associate Director, Quality Agreements, who leads day-to-day management and execution.
  • Establish and monitor vendor performance metrics and quality KPIs, reporting trends and risks to executive leadership.
  • Ensure robust processes for supplier change management, deviations, and CAPAs related to vendor activities.
  • Drive continuous improvement initiatives to enhance vendor quality systems, compliance, and efficiency.
• Cross-Functional Leadership & Influence
  • Act as a strategic partner to Technical Operations, Clinical, Regulatory, and Supply Chain teams.
  • Provide expert guidance on risk management, vendor selection, and mitigation strategies.
  • Influence decision-making at the senior leadership level through data-driven insights and quality risk assessments.
• Team Leadership & Development
  • Build, lead, and develop a high-performing Vendor Management QA team.
  • Foster a culture of quality excellence, accountability, and continuous improvement.
  • Mentor and develop talent, ensuring organizational capability scales with company growth.
• External Engagement
  • Serve as the primary QA contact for key vendors and partners.
  • Represent Quality in executive-level vendor governance meetings.
  • Ensure external partners operate in alignment with Vaxcyte’s quality standards and expectations.

Requirements: 

• BS/BA in a scientific discipline and minimum 12 years of relevant experience in GxP Quality within the biotech/pharmaceutical industry. Other combinations of education and/or experience may be considered.
• Extensive experience in vendor management, supplier quality, and audit programs.
• Deep knowledge of GMPs, FDA regulations, and ICH guidelines.
• Demonstrated expertise in risk management principles and quality systems.
• Experience supporting both clinical and commercial-stage products strongly preferred.
• Proven ability to lead teams and influence cross-functional stakeholders at senior levels.
• Strong track record of inspection readiness and regulatory interactions.
• Excellent communication, leadership, and organizational skills.
• ASQ certification (CQA, CQE) or auditor certification preferred.

Summary:

Vaxcyte is seeking a Manager, Quality Assurance, Compliance who is responsible for providing day-to-day operational oversight governance and strategic oversight of key Quality System processes, with a primary focus on leading Change Control governance and deviation/investigation oversight review board leadership. This role insures consistent, risk-based decision making, inspection readiness, and cross-functional accountability across quality systems. The Manager acts as an operational backbone a governance leader for cross-functional quality processes, proactively identifying systemic risks, ensuring procedural compliance, driving performance through KPIs, and presenting quality system health and trends through Management Review.

Essential Functions:

• Change Control Governance & Board Leadership
  • Lead and coordinate the Change Control Review Board (CCRB), including agenda development, facilitation, quorum confirmation, and documentation of decisions.
  • Perform pre-CCRB QA review of Change Requests to ensure completeness, clarity, and appropriate risk classification prior to board review.
  • Verify alignment of Change Requests with applicable SOPs, including confirmation of CCRB-required versus discretionary changes.
  • Provide QA authority on change classification, risk assessment, impact evaluation, and implementation strategy.
  • Own CCRB performance metrics, including cycle time, risk categorization trends, backlog, and recurring impact areas. Present trends and risk signals to senior leadership and during Management Review.
• Deviation and Investigation Governance
  • Lead or co-lead Deviation Review Boards to ensure consistent, risk-based decision making.
  • Ensure appropriate classification (minor, major, critical) and scientifically sound investigations.
  • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
  • Ensure linkage between deviations, CAPA, and change controls to prevent recurrence and address systemic risk.
• Quality Metrics and Management Review
  • Own development, maintenance, and reporting of Quality System KPIs related to Change Control, Deviations, Investigations, and CAPA.
  • Perform routine trend analysis and signal detection to identify emerging compliance risks.
  • Prepare and present Quality System performance data during Management Review.
• Inspection Readiness and Regulatory Support
  • Serve as Subject Matter Expert (SME) for Change Control and Deviation processes during regulatory inspections and audits.
  • Support preparation of audit responses and ensure timely and compliant closure of observations.
  • Maintain processes in a continuous state of inspection readiness.

Requirements: 

• Bachelor’s degree in Life Sciences or a related field.
• 5+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industry. Other combinations of education and/or experience may be considered.
• Experience leading cross-functional governance boards strongly preferred.
• Strong understanding of ICH Q10, risk management principles, and inspection expectations.
• Experience with electronic Quality Management Systems (eQMS) strongly preferred.
• In-depth knowledge of cGMP regulations.
• Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
• Strong interpersonal and communication skills to work effectively across functions and with external partners.