Manager, Quality Assurance for Quality Control, Commercial Product

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:

As Vaxcyte’s products progress toward late stage clinical and commercialization, Vaxcyte is initiating development of a dedicated Quality Assurance team. This position will lead all aspects of QA activities in support of the Commercial Quality Control function in Switzerland. Key duties include overseeing method validation/transfer, representing QA for QC in support of investigations, deviations, change controls and CAPAs, and QA oversight of QC activities for Vaxcyte’s intermediates and drug substances supporting the commercial PCV product. The Manager will work closely with internal teams (Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain compliance within the analytical program.

Essential Functions:

• Review validation and transfer protocols, data, and reports for analytical assays associated with the advancement of our late-phase clinical program to the commercial space.
• Act as the main contact within Vaxcyte QA for QC-specific topics as they apply to the commercial product’s intermediates and drug substances and with external partners, fostering collaborations to support analytical requirements for Vaxcyte's materials.
• Review test methods, protocols, and reports and evaluate for commercial readiness
• May review data and CoAs from CMOs with technical and compliance expertise.
• Review and support deviations, OOS/OOT result investigations, and risk assessments related to analytical testing. Act as the Analytical QA representative in internal discussions.
• Work with others to identify opportunities for continuous improvement and implement/maintain solutions.
• 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.

Requirements:

• Bachelor’s degree in Biochemistry, Chemistry, or a related field with 5+
• Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with proven expertise in applying these regulations to develop practical solutions and phase-appropriate analytical strategies.
• Experience working with biochemistry, immunoassay, or microbiological assay techniques.
• 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.

Reports to: Senior Director, Quality Assurance

Location: San Carlos, CA

Compensation:

The compensation package will be competitive and includes an equity component.

Vaxcyte Switzerland GmbH

Rottenstrasse 5

3930 Visp, Valais

Switzerland

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.

#LI-JN1