Director, Quality Control Operations

About the role

Vaxcyte, a clinical-stage vaccine company developing high-fidelity vaccines against bacterial diseases, is hiring a Director of QC Operations in Visp, Switzerland. The role leads the QC Operations team and is accountable for day-to-day Quality Control execution across the contract manufacturing and contract testing network, ensuring testing and release happen on time and that QC remains compliant and inspection-ready through VAX-31 BLA and into commercial supply. It reports to the Senior Director, Quality Control.

Key responsibilities

• Lead the QC Operations team and oversee sample flow, testing schedules and turnaround commitments across the contract testing network
• Oversight of the analytical control strategy and specifications at contract manufacturing and testing organizations, including vendor document reviews such as sampling plans, change controls and test methods
• Ensure batch release through certificate of analysis generation and timely approval of analytical results, meeting manufacturing and supply commitments
• Act as the main Global Analytical contact for routine QC with contract manufacturers and labs, running operational oversight of their performance on turnaround, quality and compliance
• Own quality incidents related to analytics (deviations, OOS/OOT results), driving root-cause closure with corrective and preventive actions, and own analytical data trending and escalation of emerging risks
• Ensure data integrity in all QC activities and maintain QC policies, SOPs, work instructions and templates, keeping them current
• Ensure QC compliance with cGMP, global regulatory requirements and internal standards, and implement the QC framework for commercial readiness
• Support regulatory inspections, pre-approval readiness and customer/partner audits, and ensure records are complete, retrievable and defensible
• Own QC training curricula, lead and coach the team across sites and time zones, plan resources to manufacturing schedules, and build a culture of accountability and collaboration with Quality Assurance

Required profile

• Bachelor of Science with 10+ years of relevant experience in the biotechnology or pharmaceutical industry
• Direct leadership of a GMP quality control function, including line management of a QC team
• Experience managing and overseeing contract laboratories and contract manufacturing organizations, including performance monitoring
• Experience supporting regulatory inspections and partner audits from a quality control standpoint
• Experience authoring GMP-controlled documents such as SOPs, work instructions and templates
• Vaccine or conjugate vaccine experience preferred

Required skills

• Comprehensive knowledge of cGMPs and multi-national regulations
• Demonstrated ownership of deviations, OOS investigations and CAPA in a GMP laboratory setting
• Excellent communication, negotiation and relationship-building skills with internal and external stakeholders
• Strong organizational, management, teamwork and interpersonal skills

What we offer

• Competitive compensation package with comprehensive benefits and an equity component
• Hybrid work arrangement (minimum of 3 days per week onsite); relocation assistance is not available