Sr. Manager, Quality Assurance for Quality Control, Drug 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: This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines. Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a Senior Manager. The position will be an integral part of the team responsible for method validation/transfer and cGMP-compliance in routine operations for analyses performed for all phases of clinical development. The primary responsibility will be the QA oversight of QC activities associated with PCV Drug Product. The Sr. Manager will work closely with internal teams (Process Development, Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain the compliance of the analytical program. Essential Functions: Review validation and transfer protocols, data, and reports for analytical assays associated with the PCV drug product program. Collaborate with Quality Control to set appropriate validation/transfer acceptance criteria. Act as the main contact within Vaxcyte QA and with external partners, fostering collaborations to support analytical requirements for Vaxcyte's PCV Drug Product programs. Work with internal stakeholders to understand methods performed onsite and at CMOs. Review test methods, protocols, data, and CoAs from CMOs with technical and compliance expertise. Give compliance feedback to stakeholders who have developed the analytical methods. Review and manage deviations, OOS/OOT results, and perform risk assessments related to drug product testing. Support vendor management for drug product testing vendors. Act as the Analytical QA representative in internal drug product discussions. Accountable for execution and oversight of processes within the quality system as they apply to PCV drug product (deviations and investigations, change controls, and CAPAs). Support regulatory submissions and responses to health authority questions during various clinical phase filings. Work with others to identify opportunities for continuous improvement and implement/maintain solutions. Provide strong teamwork in establishing a quality culture and shared accountability. Requirements: Bachelors degree in Biochemistry, Chemistry, or a related field with 9+ years of relevant industry experience. 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. Previous experience in validation and transfer of analytical assays is highly desired. 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 IND, NDA, and BLA submission is preferred. Reports to: Senior Director, Quality Assurance Location: San Carlos, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $176,000 $190,000 (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. Apply Job!