Quality Assurance Specialist III, External Manufacturing

Vaxcyte seeks a Senior Quality Assurance Specialist III in Visp to oversee GxP external manufacturing records, ensure regulatory compliance, and support product disposition and quality systems within the biologics sector.

This senior position is responsible for maintaining the integrity of external manufacturing batch records and quality documentation in alignment with Vaxcyte’s quality standards. The specialist ensures that all product disposition activities strictly adhere to established Quality Assurance policies, current Good Manufacturing Practices, and relevant Standard Requirement Documents.

Responsibilities

• Evaluate both paper-based and digital batch records, along with deviations and change controls, while serving as the main Quality Assurance liaison for the Contract Development and Manufacturing Organization (CDMO).
• Execute product disposition tasks, which encompass reviewing and approving documentation, managing archives, and analyzing raw data.
• Represent the Quality Assurance function during the investigation and resolution of deviations, change controls, and Corrective and Preventive Actions (CAPAs).
• Contribute to Technology Transfer and Validation groups by offering expertise on QA protocols and examining documentation for transfers.
• Oversee the review, revision, and approval of controlled documents while keeping precise records of all quality-related activities.
• Guarantee that all disposition tasks meet international regulatory expectations from agencies such as the FDA and EMA.
• Collaborate with global manufacturing teams and external partners to resolve quality concerns and facilitate product development.
• Identify process gaps and introduce best practices to enhance the efficiency of batch record reviews.
• Provide assistance during internal audit processes as needed.

Requirements

• Hold a Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a closely related discipline.
• Possess at least five years of professional experience in quality assurance, manufacturing, or quality systems management within the life sciences, biotechnology, or pharmaceutical sectors.
• Demonstrate extensive familiarity with cGMP, ICH guidelines, FDA and EMA regulations, and other global pharmaceutical quality standards.
• Show proven capability in managing batch record reviews and resolving deviations.
• Maintain a thorough understanding of biologics manufacturing operations.

Nice to have

• Experience conducting reviews of electronic batch records.

What the company offers

• Receive a competitive salary package.
• Enjoy a comprehensive benefits program.
• Be granted an equity component.

About the company

Vaxcyte is a clinical-stage vaccine innovation company focused on engineering high-fidelity vaccines to protect humankind from bacterial diseases. The organization fosters a culture that values creative diversity, ambitious biologics development, and a kindness-first approach to collaboration.

• Rethink convention by bringing creative and intellectual diversity to innovate vaccine delivery.
• Aim high by making the most complex biologics ever attempted to protect humankind.
• Lead with heart using a kindness-first, inclusive approach to collaboration and vigorous debate.
• Model excellence by demonstrating integrity, accountability, equality and clarity across communications and decision making.