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Head Quality Systems
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Regulatory Compliance Specialist
vor 2 Wochen
Protecting Humankind through Vaccine Innovation
Vaxcyte is a pioneering vaccine innovation company dedicated to engineering high-fidelity vaccines that safeguard humanity from the devastating consequences of bacterial diseases. Our mission is multifaceted, focusing on eradicating or treating bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella.
Our Company Vision
Guided by four enduring core values, our path to success is clear and well-defined. We Rethink Convention by bringing creative diversity to every aspect of our work, re-innovating vaccine delivery methods to drive progress. We Aim High by embodying an audacious goal, striving to courageously develop complex biologics that protect humanity. We Lead with Heart by collaboration and inclusive debate advancing our objectives as we lead with kindness-first approaches. Finally, we Model Excellence by demonstrating integrity, accountability, equality, and clarity in communications and decision-making, essential for addressing our significant challenge.
Job Description
This role will be responsible for contributing to Vaxcyte's late-stage product development and commercialization efforts by coordinating CMC activities related to Quality Control. The successful candidate will work closely with Process Development, Quality, Operations, and Regulatory functions to ensure timely, compliant, secure, and uninterrupted supply of innovative therapies. As part of the Quality Control organization for Contract Development and Manufacturing Organizations (CDMOs), this position will ensure products and services meet quality standards and regulatory requirements throughout development and manufacturing processes.
Responsibilities
- Develop and implement QC strategies aligned with the CDMO's goals, ensuring compliance with relevant regulations and industry standards.
- Establish robust quality control systems that encompass sampling, testing, documentation, and release procedures for raw materials, intermediates, and finished products.
- Evaluate and ensure contracted QC laboratories are equipped with necessary instrumentation and equipment, maintained according to regulatory requirements, and calibrated regularly for accurate test results.
- Partner with contract laboratories to oversee method validation and transfer activities between laboratories.
- Guarantee secure data management systems, including storage, retrieval, and retention of QC data and documentation, are in place, ensuring all testing activities comply with Good Documentation Practices (GDP).
- Verify and approve analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to ensure accuracy, completeness, and compliance with specifications for both release and stability testing.
- Support investigations and deviations, out-of-specification (OOS) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with internal stakeholders to implement corrective and preventive actions (CAPAs).
- Manage stability programs regarding design, data analysis, trending, and regulatory submissions, ensuring stability data are timely available, accurate, and reliable.
- Oversee reference standard qualification and maintenance.
- Provide technical support for product-related regulatory inspections.
- Write, review, and approve Quality Control-related documents to ensure compliance with applicable regulations and industry standards.
