Lead enterprise-wide efforts to structure, govern, and utilize data and knowledge assets to support process development, clinical, and regulatory activities. Establish systems to capture institutional knowledge and ensure data integrity for commercial regulatory submissions.
Vaxcyte
13 Remote Job Openings at Vaxcyte
Lead QA oversight for QC activities related to drug substances and polysaccharides across multiple global sites. Manage internal QA teams and external partners to ensure compliance with global regulatory guidelines and support vaccine pipeline development.
Format and finalize complex regulatory documents for submission to health authorities using Word and Adobe Acrobat Pro. Collaborate within Veeva RIM to ensure consistency with internal templates and style guides while managing literature lists.
Lead and facilitate commercial process validation and risk management activities across end-to-end manufacturing processes. Coordinate technical strategies and cross-functional efforts to ensure commercial readiness and regulatory compliance.
Senior Manager, Global Drug Substance Commercialization, Conjugation
Vaxcyte
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Full Time
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a month ago
Vaxcyte
Lead the launch readiness and commercial supply of conjugate drug substances, transitioning product strategy from Process Development to MSAT. Coordinate cross-functional efforts for regulatory filings, facility readiness, and the technical execution of commercialization strategies.
Develop and execute global regulatory CMC strategies for investigational products and lead the preparation of regulatory submissions. Manage interactions with Health Authorities and provide regulatory guidance to cross-functional teams to ensure global compliance.
Lead launch readiness and commercial supply of polysaccharides for glycoconjugate vaccines, focusing on technical planning and regulatory filings. Coordinate cross-functional efforts to ensure process robustness and seamless transition from development to commercial manufacturing.
Serve as the CMC statistical lead for the Vaccine Specification Working Group, providing leadership for specification setting and justification across late-stage development and commercial lifecycle management. Collaborate with cross-functional teams to develop statistically sound, regulatory-ready approaches for drug substance and drug product testing.
Lead microbiological quality control activities and ensure cGMP compliance for clinical development and commercialization of vaccine products. Manage outsourced testing at Contract Testing Organizations and oversee quality event management including deviations and investigations.
The Medical Science Liaison serves as a scientific expert in immunization and pneumococcal disease prevention, acting as a partner to healthcare providers and public health officials. Responsibilities include managing stakeholder relationships, supporting clinical development, and gathering field insights to inform vaccine strategy.
Associate Director, Process Validation and Risk Management
Vaxcyte
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Full Time
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3 months ago
Vaxcyte
The Associate Director will lead commercial process validation and risk management strategies across end-to-end manufacturing processes. This role involves cross-functional coordination to ensure regulatory compliance, successful technology transfer, and product lifecycle management.
Lead strategic planning and execution of the companyβs first launch of VAX-31, coordinating cross-functional activities from late-stage development through market entry. Partner with senior leadership to define launch strategies, manage timelines, mitigate risks, and drive alignment across stakeholders.
The AI Implementation Consultant will support the design, evaluation, and implementation of AI solutions within the Legal and Compliance functions. This includes developing AI-powered tools, enhancing existing dashboards, and collaborating with cross-functional teams to drive efficiency and compliance.