Vaxcyte

Director

• Lead and facilitate launch readiness and commercial supply of glycoconjugate drug substances, including polysaccharide activation, conjugation, and associated raw materials
• Lead technical launch planning and execution for regulatory filings, facility readiness, and launch supplies
• Ensure effective communication of scientific and commercial rationale for critical raw material manufacturing processes to internal stakeholders, CMOs, and regulatory agencies
• Plan and execute commercial lifecycle management activities
• Provide strategic and scientific leadership for polysaccharide activation and conjugation processes
• Build and develop a highly skilled global conjugation manufacturing team and support staffing recommendations
• Continuously improve process understanding and robustness by monitoring, trending, and optimizing operations
• Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering teams
• Support technical transfers and integration of new technologies
• Support internal and external manufacturing networks, materials management, and data analytics
• Lead process validation and comparability activities
• Review and author regulatory filings and respond to health authority questions
• Communicate process performance to internal and external stakeholders
• Serve as DS Commercialization lead for Conjugation within Global Manufacturing Operations

Director, Global Drug Substance Commercialization, Conjugation

Clinical Operations

• Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, SOPs and project-specific guidelines/instructions.
• Manage Quality Issues and serious breach investigations.
• Review and approve Investigations, Root Cause Analysis, CAPA and Effectiveness Check plans.
• Track quality events from Quality Issues, Audits, Inspections and similar QA activities until closure.
• Manage and oversee quality event updates in eQMS.
• Plan, schedule and conduct risk-based and For Cause audits of clinical investigator sites, CROs and other GCP vendors.
• Support regulatory agency inspection readiness, including mock inspections, gap assessments and inspection response coordination.
• Evaluate policies and procedures for regulatory compliance and recommend continuous process improvements.
• Support QA initiatives and process improvement projects.
• Promote a quality mindset and quality excellence across activities.
• Interpret regulatory agency policies and guidance related to GCP requirements and assist with implementing compliant processes at Vaxcyte.
• Report to the Senior Director, Clinical Quality Assurance.

Director, Global Drug Substance Commercialization, Conjugation

Senior Manager, Clinical Quality Assurance