Director, Global Quality Assurance, Clinical Development and Operations

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases. 

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!

Position Summary:

Reporting to the Sr. Director of Global Quality Assurance, Clinical Development and Operations, the Director of Global Quality Assurance, GCP/GLP/Pharmacovigilance (GPV), is responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical operations and development programs, including conducting, managing, and overseeing audits, managing quality issues, investigations, and inspections. Additionally, this role is accountable for GCP/GPV/GLP oversight, and for assuring the compliance of studies with our Company’s Standard Operating Procedures (SOPs), policies, and all applicable global regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations); and will play a key role in process improvement, compliance, and inspection readiness.

Key Responsibilities:

• Develop and maintain the audit plans to assess GCP/GPV/GLP compliance across all clinical and pre-clinical operations.
• Conduct on-site, hybrid, and/or remote audits, documenting findings and providing actionable recommendations.
• Prepare and present audit reports to senior management and relevant stakeholders.
• Manage ongoing GCP QA day-to-day activities associated with Clinical Operations.
• Establish, manage, track, and provide status reports for Quality Objectives, and Priorities.
• Collaborate with clinical operations and clinical regulatory teams to develop and refine standard operating procedures (SOPs) related to GCP, GLP and GPV.
• Serve as the Quality Business Partner (QBP) point of contact for Clinical Operations, Data Management, Clinical Regulatory Affairs and Medical Writing.
• Internal trend analysis of audit observations and identifies/communicates to QA Management all compliance risks.
• Collaborate with technical functions to support inspection readiness projects.
• Ensure rapid communication of Quality issues, including potential misconduct, issues of significance with project/product for Health Authorities, business partners and senior management.
• Support activities related to key QMS programs, including Supplier Quality Management (SQM), audit, and Inspection readiness and management.
• Monitors Quality Assurance, Clinical Operations metrics, reporting, and cross-functional review forums, including the Quality Management Review process.
• Lead and support GCP/GPV/GLP health authority inspections and provide GCP compliance technical support during inspections of investigator sites.
• Stay current with industry trends, regulations, and best practices to ensure the organization remains compliant.
• Other duties as assigned per business needs.
• Interact with third-party vendors and business partners to ensure compliance with Quality standards.
• Build rapport and trust with internal stakeholders in accordance with Zenas values, TRUE Innovation.

Qualifications: 

• Bachelor’s degree and 10+ years’ experience managing Quality activities related to GCP, GPV, and GLP in Clinical Development and Operations in the Biopharmaceutical industry.
• Extensive knowledge of Quality Assurance principles, practices, and standards.
• GCP, GPV, and GLP compliance expertise including knowledge of applicable regulatory requirements for US FDA, China, EU, and ICH.
• Comprehensive knowledge of compliance requirements and best practices for building and maintaining the systems, processes, and tools needed for Quality oversight of GCP, GPV, and GLP activiti