Quality Assurance Specialist III, External Manufacturing - job 1 of 2

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:

The Quality Assurance Specialist (QA) III, External Manufacturing will play a pivotal role in ensuring that all GxP external batch records adhere to Vaxcyte’s quality standards and regulatory requirements. This individual will perform activities supporting dispositioning parenteral drug products, intermediates, and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Vaxcyte’s Standard Requirement Documents. The ideal candidate will possess in-depth knowledge of cGMP (current Good Manufacturing Practices) and regulatory guidelines within the pharmaceutical industry. The QA Specialist III will also be responsible for assisting in the implementation of the ERP platform activities as appropriate.

• GxP Batch Record and Product or Program Document Review for raw materials, drug product intermediates, and/or parenteral drug products: Reviewing executed batch records, product or program specific documents, deviation and change control review and approval, documenting batch review comments, and effectively working with cross functional team, may be the primary QA point of contact with CDMO.
• Product Disposition: Performing activities associated with disposition of product (e.g. document review and approval, document archival, raw data review).
• Problem Solving: Representing Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. Effective, independent conflict resolution.
• Technology Transfer and Validation: May participate as a QA representative on Technology Transfer and/or Validation Teams where responsibilities include providing guidance on QA procedures and policies as well as review of documents for both internal and external transfers.
• Documentation and Reporting: Reviewing, editing, or approving controlled documents. Maintain accurate and thorough documentation of related quality activities.
• Regulatory Compliance: Ensure all disposition-related activities comply with global regulatory requirements, including FDA, EMA, ICH guidelines, and other applicable regulations.
• Cross-functional Collaboration: Work closely with global manufacturing, and external vendors to address quality issues and support product development and commercialization.
• Continuous Improvement: Drive improvements in batch record review processes and procedures by identifying gaps, recommending solutions, and implementing best practices.
• Participate in activities for the implementation of the ERP platform. 
• Support internal audits as required.

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a related field. Minimum of 5+ years of experience in quality assurance, batch record review, manufacture, or quality systems management within the pharmaceutical, biotechnology, or life sciences industry.
• Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards.
• Demonstrated experience managing batch record review and deviation resolution.
• Great organization skills and have an attention to detail.
• In-depth understanding of biologics manufacturing operations.
• Good ability to prioritize multiple assignments and changing priorities.
• Excellent problem-solving skills and the ability to manage complex investigations and root cause analyses.
• Strong written and verbal communication skills, with the ability to clearly present quality issues to cross-functional teams.

Reports to: Director, Quality Assurance, Drug Product

Location: San Carlos, CA; Hybrid

Compensation:

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

Salary Range: $120,000 – $141,000

Vaxcyte, Inc.

825 Industrial Road, Suite 300

San Carlos, CA 94070

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.