Careers

Vice President, Head of Quality

Position Summary

The Vice President, Head of Quality will lead the transformation of ArriVent’s Quality organization to support pre-commercial and commercialization activities. The VP will build on ArriVent’s culture of Quality and establish strong cross functional relationships with key stakeholders, including Clinical, Medical, Safety & PV, Regulatory, and Commercial, while leading ArriVent’s Quality team. The VP leads ArriVent’s enterprise Quality function and provides independent oversight of GxP activities across clinical development, manufacturing, commercial readiness, and supply. Reporting to a member of the Executive Leadership Team the VP establishes the Quality strategy, governance model, organization, and scalable GxP Quality Management System required to support the pipeline of small molecule and antibody drug conjugates (ADCs), regulatory commitments, external partnerships, and company growth.

Major Duties and Responsibilities

Quality Strategy, Governance, and Organization

• Define and execute the enterprise Quality strategy spanning GCP, GMP, and GLP.
• Establish and maintain a risk-based GxP Quality Management System supporting clinical development, manufacturing, product release, regulatory submissions, and commercial readiness.
• Establish Quality policies, standards, governance, metrics, escalation pathways, and decision authorities for internal and outsourced activities.
• Serve as the independent Quality advisor to executive leadership, communicating material risks, trends, resource needs, remediation plans, and recommendations.
• Lead Quality governance and provide oversight of significant quality events, critical deviations, serious breaches, investigations, CAPAs, inspection findings, and regulatory commitments.
• Lead and continue developing ArriVent’s high performing Quality team.

GCP Quality and Clinical Compliance

• Lead GCP Quality oversight across clinical development programs, including clinical sites, CROs, laboratories, vendors, computerized systems, clinical data processes, and safety interfaces.
• Partner with Clinical Development, Clinical Operations, Biostatistics, Data Management, Drug Safety, Medical Affairs, and Regulatory Affairs to support compliant trial conduct, documentation, data integrity, and sponsor oversight.
• Establish and oversee the risk-based GCP audit program, including investigator site, CRO, vendor, process, system, and internal audits.
• Direct the management of significant GCP quality events, serious breaches, suspected misconduct, inspection findings, investigations, CAPAs, and effectiveness checks.
• Maintain clinical inspection readiness and lead Quality support for health authority inspections and related responses.
• Monitor GCP compliance risks and trends, directing corrective or preventive action when needed.

GMP Quality and Product Quality

• Lead GMP Quality oversight across external manufacturing, testing, packaging, labeling, storage, distribution, and supply activities.
• Govern the qualification, oversight, and performance of CMOs, contract laboratories, depots, suppliers, and other GMP service providers.
• Oversee product disposition and release processes, including applicable batch records, analytical data, deviations, investigations, change controls, specifications, validation records, and product quality documentation.
• Direct Quality Agreements, supplier quality management, complaints, recalls, stability-related quality matters, and product quality reviews, as applicable.
• Partner with Technical Operations, CMC, Supply Chain, Regulatory Affairs, and external partners on technology transfers, process validation, comparability, scale-up, launch readiness, and supply continuity.
• Assess product quality and compliance risks, escalating material issues and directing timely resolution.

Quality Systems, Inspection Readiness, and Executive Leadership

• Oversee the design and effectiveness of Quality Systems, including document control, training, deviations, investigations, CAPA, change control, audits, vendor qualification, risk management, management review, and data integrity.
• Approve the enterprise GxP audit plan and oversee internal, vendor, and partner audits.
• Support health authority inspection readiness, inspection management, regulatory responses, remediation commitments, and effectiveness monitoring.
• Govern computerized systems and records supporting GxP activities through appropriate validation, security, access, retention, and data integrity controls in partnership with system owners.
• Monitor regulatory requirements and expectations, translate changes into business requirements, and direct implementation across the organization.
• Incorporate Quality considerations into portfolio, program, supply, regulatory, partnership, and operating decisions.
• Present Quality strategy, risks, metrics, inspection readiness, and remediation status to executive leadership and other governance bodies.
• Represent ArriVent in Quality matters with health authorities, partners, auditors, consultants, and external service providers.
• Balance patient protection, product quality, compliance, business continuity, and program needs while maintaining independent Quality judgment.

Position Requirements

• Bachelor’s degree in life sciences, pharmacy, engineering, or a related discipline. An advanced degree is preferred.
• At least 15 years of progressive Quality, compliance, or related GxP experience in the pharmaceutical or biopharmaceutical industry, including significant leadership responsibility. Experience with small and large molecule products, including ADCs, preferred.
• Direct leadership and practical experience across both GCP and GMP Quality.
• Experience leading an enterprise or multidisciplinary Quality function in a clinical-stage and commercial biopharmaceutical environment.
• Experience building or scaling a risk-based Quality Management System and governance model.
• Experience supporting health authority inspections, inspection responses, remediation plans, and regulatory commitments.
• Experience overseeing outsourced development and manufacturing models, including CROs, CMOs, laboratories, clinical sites, suppliers, and other GxP providers.
• Working knowledge of applicable U.S. and global GxP requirements, including GCP, GMP, data integrity, and computerized system controls.
• Experience supporting late-stage development, regulatory submissions, pre-approval or equivalent inspection readiness, and commercial launch is strongly preferred.
• Ability to assess complex risks, make independent decisions, escalate material issues, and influence senior leaders across functions.
• Strong written, verbal, facilitation, negotiation, and executive presentation skills.