Summary:

The Director, Business Operations (Global QC) will lead the strategic design, implementation, and continuous optimization of global operational frameworks supporting Vaxcyte’s Quality Control (QC) and supporting Analytical interfaces. This role ensures that analytical inputs and QC operations are scalable, compliant, efficient, and aligned with corporate and regulatory expectations as the organization advances from development through commercial readiness.

The Director will serve as the central business operations leader for the Global Quality Control, partnering with leaders in Analytical Development, Analytical Science & Technology, Stability, Process Development, Manufacturing Science and Technology (MS&T), and Quality. This individual will drive governance, process standardization, infrastructure development, and cross-functional coordination to enable timely, compliant, and uninterrupted supply of Vaxcyte’s innovative vaccines.

Essential Functions:

Operational Excellence & Strategy
•    Lead the design and execution of operational strategies that translate Vaxcyte’s global vision into efficient, compliant, and scalable QC and analytical business operations.
•    Develop and maintain a global QC operations strategy, ensuring alignment with clinical and commercial objectives.
•    Implement continuous improvement frameworks (e.g., Plan-Do-Check-Act) to enhance efficiency, scalability, and compliance across analytical and QC processes.
•    Define and monitor key performance indicators (KPIs) that assess operational performance, quality, delivery timelines, and cost efficiency across the global analytics network.
•    Partner with cross-functional leaders to ensure analytical and QC infrastructure, systems, and processes are integrated into overall business objectives.
•    Lead initiatives that improve operational automation, data visibility, and process robustness.

Governance & Compliance
•    Establish and maintain robust governance frameworks for QC and analytical operations in alignment with global cGMP regulations and internal quality standards.
•    Define, visualize, and formalize QC business processes using RASCI principles, ensuring clear ownership and accountability across the analytical network.
•    Review and enhance the Quality Management System (QMS) infrastructure to close gaps, harmonize SOPs, and strengthen procedural consistency.
•    Ensure data integrity principles are embedded in all operational practices, compliant with Vaxcyte’s DI policies and global standards.
•    Support global inspection readiness and lead preparations for regulatory inspections, partner audits, and customer reviews.
•    Collaborate with Quality to ensure analytical operations and contract testing laboratories meet all compliance requirements.

Infrastructure & Systems Leadership
•    Oversee the development and validation of business systems, data management platforms, and documentation practices across global analytical and QC sites.
•    Ensure that contract and in-house laboratories maintain robust equipment qualification, calibration, and maintenance programs to support reliable analytical testing.
•    Lead network and site planning activities, including external partnerships and outsourcing strategies with CDMOs and CROs.
•    Develop business cases for laboratory expansion, outsourcing scenarios, and infrastructure investments to support strategic growth.

Capability Building & Team Leadership
•    Collaborate and mentor a global team of QC operations professionals to ensure scientific, technical, and operational excellence.
•    Drive training programs that enhance technical proficiency, compliance culture, and cross-functional understanding within the analytics organization.
•    Foster a culture of innovation, learning, and continuous improvement across the analytical network.
•    Collaborate closely with functional heads across Analytical Development, Analytical Science and Technology, Stability, and Manufacturing to harmonize operational practices.
•    Represent Global Analytics and QC Operations in governance bodies, steering committees, and cross-functional business forums.

Requirements: 

•    Bachelor’s or Master’s degree (or higher) in Biotechnology, Pharmaceutical Sciences, Engineering, or related field.
•    12+ years of progressive experience in Quality Control, Analytical Operations, or Technical Operations within a biotechnology or pharmaceutical company.
•    Demonstrated leadership in developing and managing operational systems in GMP-regulated environments.
•    Strong understanding of cGMP, global regulatory requirements, and analytical testing operations.
•    Proven ability to design and implement business processes, governance models, and performance management systems.
•    Experience with vendor management and collaboration with CDMOs/CROs on analytical testing and QC operations.
•    Exceptional communication, negotiation, and relationship-building skills with internal and external stakeholders.
•    Strong analytical, organizational, and problem-solving skills; adept at data-driven decision-making.
•    Demonstrated passion for process improvement, operational efficiency, and automation