Director, Quality Control Operations in Raron

pbJoin our Mission to Protect Humankind! /b /p pVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. /p h3WHAT We Do Is Every Bit As Important As HOW We Do It! Our Work Together Is Guided By Four Enduring Core Values /h3 ul liRETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. /li liAIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. /li liLEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. /li liMODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. /li /ul h3Summary /h3 pThe Director of QC Operations leads the QC Operations team and is accountable for day-to-day Quality Control execution across Vaxcyte contract manufacturing and contract testing network. The role ensures the current business has the QC support it needs, that testing and release happen on time, and that Quality Control operates in a compliant, inspection-ready state through VAX-31 BLA and into commercial supply. /p pAs the executive function of Quality Control, the role provides leadership and oversight for implementation of the approved analytical control strategy and specifications at the contract manufacturing and contract testing organizations. Working closely with Analytical Development, Analytical Science and Technology, Stability, Quality Assurance, Regulatory Affairs, and the Analytical Technical Leads, this role is critical to timely, compliant, and uninterrupted release of Vaxcyte products. /p h3Essential Functions /h3 ul liDay-to-Day QC Execution and Release ul liLeads the QC Operations team and is accountable for sample flow, testing schedules, and turnaround commitments across the contract testing network. /li liProvides leadership and oversight for implementation of the analytical control strategy and specifications at the contract manufacturing and contract testing organizations, as set through project team governance. /li liOversight on reviews and approval of vendor documents supporting execution, including sampling plans, change controls, and test methods. /li liEnsures that QC operations deliver batch release through certificate of analysis generation and timely review and approval of analytical results. /li liEnsures on-time testing and release so that manufacturing and supply commitments are met. /li /ul /li liVendor Collaboration and Oversight ul liActs as the main Global Analytical contact for QC routine operation with contract manufacturing and contract testing organizations. /li liRuns day-to-day operational oversight of external laboratories, including performance against agreed turnaround, quality, and compliance expectations. /li liStrengthens vendor collaboration through dedicated and focused working sessions and escalates commercial and contractual matters to Global Analytics and Technical Operations. /li /ul /li liQuality Events, Investigations, and Data ul liTakes ownership of cross-component quality incidents related to analytics, including deviations, laboratory investigations, and out-of-specification and out-of-trend results, driving them to root-cause-based closure with corrective and preventive actions. /li liEnsures that QC Operations takes ownership or provide support on quality incidents related to analytics, including deviations, laboratory investigations, and out-of-specification and out-of-trend results, driving them to root-cause-based closure with corrective and preventive actions. /li liOwns trending of analytical data related to release and escalates emerging risk to the Head of Quality Control and the relevant Analytical Technical Lead. /li liEnsures data integrity principles are applied in all QC activities in compliance with Vaxcyte policies, guidelines, and procedures. /li /ul /li liControlled Documentation and Compliance ul liAuthors and maintains the QC policies, standard operating procedures, work instructions, and templates that describe how QC operates today, and keeps them current as the process changes. /li liEnsures QC activities comply with cGMP, global regulatory requirements, and internal standards. /li liImplements the QC framework and governance developed for commercial readiness into routine QC practice. /li /ul /li liAudit and Inspection Support ul liSupports regulatory inspections, pre-approval inspection readiness, and customer and partner audits with QC due diligence, documentation, and subject matter expertise. /li liEnsures QC records, results, and investigations are complete, retrievable, and defensible. /li /ul /li liTeam Leadership and Capability ul liTakes ownership of QC operations training curricula and status of training. /li liLeads, develops, and coaches the QC Operations team across sites and time zones, setting clear priorities and performance expectations. /li liPlans QC Operations resources in alignment with manufacturing and testing schedules so that analytical deliverables and testing are carried out to quality standards. /li liBuilds a culture of accountability, learning, and collaboration, and partners with Quality Assurance as one quality unit. /li /ul /li /ul h3Requirements /h3 ul liBachelor of Science with 10+ years of relevant experience in the biotechnology or pharmaceutical industry. /li liDirect leadership of a GMP quality control function, including line management of a QC team. /li liExperience managing and overseeing contract laboratories and contract manufacturing organizations, including performance monitoring. /li liComprehensive knowledge of cGMPs and multi-national regulations. /li liDemonstrated ownership of deviations, out-of-specification investigations, and corrective and preventive actions in a GMP laboratory setting. /li liExperience supporting regulatory inspections and partner audits from a quality control standpoint. /li liExperience authoring GMP controlled documents, including standard operating procedures, work instructions, and templates. /li liExcellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders. /li liStrong organizational, management, teamwork, and interpersonal skills, and professionalism required. /li liRelentless focus and passion around process improvements, efficiency, and automation. /li liVaccine or conjugate vaccine experience preferred. /li /ul h3Reports to /h3 pSenior Director, Quality Control /p h3Location /h3 pVisp, Switzerland /p h3Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy) /h3 pHybrid (minimum of 3 days per week onsite) /p h3Compensation /h3 pThe compensation package will be competitive and includes comprehensive benefits and an equity component. /p h3Relocation /h3 pThis role is not eligible for relocation assistance. /p h3Equal Opportunity /h3 pWe are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. /p #J-18808-Ljbffr