{"id":3411056,"url":"https://alion.io/job/vaxcyte-director-quality-control-operations","title":"Director, Quality Control Operations","company":{"id":685268,"name":"Vaxcyte","domain":"vaxcyte.com","url":"https://alion.io/company/vaxcyte","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":89,"open_postings":18,"ghost_share":0,"stale_share":0.222,"repost_share":0,"time_to_fill_p50_days":74,"computed_at":"2026-11-09T06:03:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Visp, Switzerland"],"countries":["CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":144000,"max_usd":344000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":841},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-28T15:51:26Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-11-09T05:43:04Z","board_verified":true,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":11},"description":"Join our Mission to Protect Humankind!\nVaxcyte 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. \nWHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:\n*RETHINK 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.\n*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.\n*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.\n*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.\nSummary:\nThe 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.\nAs 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.\nEssential Functions:\nDay-to-Day QC Execution and Release\nLeads the QC Operations team and is accountable for sample flow, testing schedules, and turnaround commitments across the contract testing network.\nProvides 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.\nOversight on reviews and approval of vendor documents supporting execution, including sampling plans, change controls, and test methods.\nEnsures that QC operations deliver batch release through certificate of analysis generation and timely review and approval of analytical results.\nEnsures on-time testing and release so that manufacturing and supply commitments are met.\nVendor Collaboration and Oversight\nActs as the main Global Analytical contact for QC routine operation with contract manufacturing and contract testing organizations.\nRuns day-to-day operational oversight of external laboratories, including performance against agreed turnaround, quality, and compliance expectations.\nStrengthens vendor collaboration through dedicated and focused working sessions and escalates commercial and contractual matters to Global Analytics and Technical Operations.\nQuality Events, Investigations, and Data\nTakes 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.\nEnsures 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.\nOwns trending of analytical data related to release and escalates emerging risk to the Head of Quality Control and the relevant Analytical Technical Lead.\nEnsures data integrity principles are applied in all QC activities in compliance with Vaxcyte policies, guidelines, and procedures.\nControlled Documentation and Compliance\nAuthors 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.\nEnsures QC activities comply with cGMP, global regulatory requirements, and internal standards.\nImplements the QC framework and governance developed for commercial readiness into routine QC practice.\nAudit and Inspection Support\nSupports regulatory inspections, pre-approval inspection readiness, and customer and partner audits with QC due diligence, documentation, and subject matter expertise.\nEnsures QC records, results, and investigations are complete, retrievable, and defensible.\nTeam Leadership and Capability\nTakes ownership of QC operations training curricula and status of training.\nLeads, develops, and coaches the QC Operations team across sites and time zones, setting clear priorities and performance expectations.\nPlans QC Operations resources in alignment with manufacturing and testing schedules so that analytical deliverables and testing are carried out to quality standards.\nBuilds a culture of accountability, learning, and collaboration, and partners with Quality Assurance as one quality unit.\nRequirements: \nBachelor of Science with 10+ years of relevant experience in the biotechnology or pharmaceutical industry.\nDirect leadership of a GMP quality control function, including line management of a QC team.\nExperience managing and overseeing contract laboratories and contract manufacturing organizations, including performance monitoring.\nComprehensive knowledge of cGMPs and multi-national regulations.\nDemonstrated ownership of deviations, out-of-specification investigations, and corrective and preventive actions in a GMP laboratory setting.\nExperience supporting regulatory inspections and partner audits from a quality control standpoint.\nExperience authoring GMP controlled documents, including standard operating procedures, work instructions, and templates.\nExcellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders.\nStrong organizational, management, teamwork, and interpersonal skills, and professionalism required.\nRelentless focus and passion around process improvements, efficiency, and automation.\nVaccine or conjugate vaccine experience preferred.\nReports to: Senior Director, Quality Control \nLocation: Visp, Switzerland \nWork Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): \nHybrid (minimum of 3 days per week onsite) \nCompensation:\nThe compensation package will be competitive and includes comprehensive benefits and an equity component.\nRelocation: \nThis role is not eligible for relocation assistance. \nEqual Opportunity\nWe 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.\nRecruitment Fraud Notice\nPlease be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. 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