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 Sr. Quality Assurance (QA) Specialist, External Manufacturing will play a pivotal role in ensuring that all external batch records adhere to Vaxcyte's quality standards and regulatory requirements. This individual will perform activities supporting dispositioning 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), regulatory guidelines within the pharmaceutical industry.
Essential Functions:
- Batch Record Review: Reviewing executed batch, resolving discrepancies records and batch review comment sheets and effectively working with cross functional team, may be point of contact with CDMO.
- Product Disposition: Performing activities associated with disposition of product (e.g. document review, shipping).
- Problem Solving: Representing Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
- Technology Transfer: May participate as a QA representative on Technology Transfer 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 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.
Requirements:
- 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 deviations.
- Great organization skills and have an attention to details.
- 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, External Manufacturing
Location: San Carlos, CA
Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $148,000 - $157,000 (SF Bay Area). Salary ranges for non-California locations may vary.
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.