• 
  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.

Essential Functions:

• QA Representative for quality management of commercial analytical activities for Vaxcyte intermediates and/or drug substances.
• Represent QA at internal and external cross functional team meetings.
• Key participants in quality team focused on the oversight of analytical processes and results at CMOs in support of commercial testing.
• Review and approve internal and external documentation for compliance, such as analytical methods and their validation protocols and reports, risk assessments, change controls, deviations and CAPAs as they relate to QC for Vaxcyte intermediates and drug substances.
• Review test methods, protocols, and reports and evaluate for commercial readiness.
• May review raw data and CoAs from CMO’s with technical and compliance expertise.
• Review and approve specifications and CoAs for intermediates and drug substances.
• Review and approve all documentation related to reference standards for intermediates and drug substances, where applicable.
• Establish, review, and periodically update GMP related internal procedures and policies, as needed.
• Maintain appropriate compliance for analytical testing of intermediates and drug substances.
• Support process improvement initiatives.
• Interact with key stakeholders to develop solutions to complex issues.
• Provide strong teamwork in establishing a quality culture and shared accountability across local and global Quality Assurance teams.
• Supports Quality Management Review to monitor product quality, process performance, and effectiveness of the quality management system.
• May participate in compliance audits as required.
• Promote a quality mindset and quality excellence approach to all activities.

Requirements:

• Bachelor’s degree in Biochemistry, Chemistry, or a related field with 9+ years of relevant industry experience.
• Demonstrate in-depth knowledge of GMPs, FDA regulations and ICH guidelines.
• Experience in analytical method validation and basic laboratory methodology is desired.
• Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.
• Strong written and verbal communication skills, including the ability to work effectively in cross-functional teams.
• Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
• Ability to work globally with CMOs in different countries and continents.
• Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
• Experience in commercial launch desired.
• Experience in overseeing QC activities in a commercial facility.
• Fluency in spoken and written English.