Director, Global Quality Assurance, GVP

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Zenas BioPharma is a global biopharmaceutical company dedicated to developing and commercializing immune‑based therapies worldwide. With clinical development and operations globally, Zenas is advancing a deep, balanced global portfolio of first‑ and best‑in‑class autoimmune therapeutics in high unmet medical need areas, while meeting dynamic value requirements in the global healthcare environment. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve lives of patients living with autoimmune and rare diseases.

Position Summary

The Director of Global Quality Assurance, GVP serves as a key quality partner across global clinical trial and pharmacovigilance teams. The role leads, oversees, and executes Good Pharmacovigilance Practices (GVP) activities, supporting high‑quality standards, mitigating risks, driving process improvement, and ensuring inspection readiness. This position reports to the Head of Global QA, Clinical Operations and Development.

Key Responsibilities

• Apply depth and breadth of GVP expertise while performing QA oversight for multiple studies / CROs.
• Drive the global GVP QA strategy and execute day‑to‑day activities to align with corporate objectives and regulatory expectations.
• Partner cross‑functionally to ensure integrated quality oversight and consistent application of GVP principles.
• Lead or support internal and external audits of PV processes, systems, and documentation to verify compliance with GCP, GVP, and applicable regulations.
• Identify potential quality risks in pharmacovigilance processes and implement proactive mitigation strategies. Drive continuous improvement initiatives in quality systems and processes.
• Establish and track KPIs and quality metrics to evaluate the effectiveness of QA activities and identify areas for improvement.
• Ensure PV Quality Agreements with business partners are defined, implemented, and monitored.
• Provide executive‑level reporting of compliance risks, trends, and audit outcomes to senior leadership and governance committees.
• Contribute to budget planning and resource allocation for GVP QA and PV audit programs.
• Oversee the maintenance of quality documentation, SOPs, and audit trail integrity related to pharmacovigilance activities.
• Provide expert interpretation of evolving global pharmacovigilance regulations and guide senior leadership on compliance impact.
• Ensure all pharmacovigilance activities adhere to applicable regulations (e.g., ICH‑GCP, FDA, EMA), company policies, and industry standards.
• Stay current with industry trends, regulations, and best practices to maintain organizational compliance.
• Prepare the organization for external inspections by regulatory authorities, ensuring documentation and processes are inspection ready.
• Interact with third‑party vendors and business partners to ensure compliance with quality standards.

Qualifications

Compensation & Benefits

Base salary range : $176,000 to $220,000 per year.

Additional compensation includes annual performance bonus, equity, and a full range of benefits such as health, dental, vision, retirement plans, and other incentive compensation.

Zenas BioPharma is proud to be an equal‑opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.

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