Senior Manager, Quality Control, Reference Standards

Role Summary

We are seeking a Sr. Manager for our Quality Control (QC) Reference Standards team to oversee the management and continuous supply of reference standards and critical reagents for testing and releasing clinical and commercial products. This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines. The Sr. Manager will work closely with internal teams (Process Development, Quality Assurance, Regulatory, Supply Chain, and Commercial) and external partners (CDMOs, CTLs, and CROs) to maintain the integrity of the reference standard program.

Location: San Carlos, CA; Open to Remote.

Responsibilities

• Reference Standards Management: Oversee the implementation and maintenance of the reference standards and critical reagent program, ensuring compliance with cGMP and ICH guidelines.
• Program Development: Support the development of global business practices, policies, and standards for reference standards and critical reagents, including qualification, requalification, and inventory management.
• Documentation and Compliance: Collaborate in the authoring and review of technical protocols, qualification reports, requalification reports, and Certificates of Analysis (CoAs) related to reference standards. Ensure timely updates to SOPs and other relevant documentation.
• Inventory Management: Manage supply chain logistics, including inventory and space planning, to ensure a continuous supply of qualified reference standards and critical reagents.
• Collaboration and Communication: Serve as a key point of contact within Vaxcyte QC and with external partners, fostering productive collaborations to support the company's vaccine programs.
• Technical Expertise: Provide technical guidance on assay qualification and validation to meet regulatory standards, and review test methods and release documentation for reference standards.
• Quality Oversight: Review and manage deviations, OOS/OOT results, and conduct risk assessments related to reference standards and critical reagents.

Qualifications

• Bachelor‚Äôs, Master‚Äôs, or Ph.D. in Biochemistry, Chemistry, or a related field. Ph.D. with 5+ years of relevant QC experience, or MS with 7+ years of experience, or BS with 9+ years of experience, including significant experience in reference standard management. Other combinations of education and/or experience may be considered.
• Strong background in cGMP and ICH regulatory guidance associated with reference standards and critical reagents.
• Experience working with biochemistry, immunoassay, or microbiological assay techniques.
• Familiarity with statistical software (e.g., JMP) for data analysis, trending, and process optimization.
• 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.
• Proficiency in LIMS and other laboratory data management systems is preferred.

Skills

• Technical guidance on assay qualification and validation to meet regulatory standards
• Review of test methods and release documentation for reference standards
• Effective collaboration with internal and external partners

Education

• Ph.D. or equivalent in Biochemistry, Chemistry, or related field preferred, with significant QC experience in reference standards
• Alternative combinations of advanced degrees and experience considered

Additional Requirements

• Location: San Carlos, CA; Open to Remote