Director, Global Quality Assurance, GCP/GLP

Responsibilities

• Support study teams and execute oversight activities, for example, attend study team meetings, collect and perform analysis of study health metrics, review study plans, advise study teams regarding matters of quality and compliance related to issues, risks, investigations, and CAPA's.
• Conduct on-site, hybrid, and/or remote vendor or clinical site audits and or inspection readiness visits.
• Establish, manage, track, and provide status reports for Quality Objectives, and Priorities.
• Serve as the Quality Business Partner (QBP) point of contact for assigned functions.
• Manage ongoing QA for ongoing GCP and GLP day-to-day activities cross-functionally and serve as the quality subject matter expert on applicable regulatory requirements and guidance.
• Provide executive-level reporting of compliance risks, trends, and audit outcomes to senior leadership and governance committees.
• Ensure rapid communication of Quality issues, including potential misconduct, issues of significance with project/product for Health Authorities, business partners and senior management.
• Lead and support health authority inspections (sponsor and sites) and lead inspection readiness activities for assigned studies.
• Collaborate with clinical operations and other functions to develop and refine standard operating procedures (SOPs) related to GCP and GLP.
• Support activities related to key Quality Management System (QMS) programs, including Supplier Quality Management (SQM), audits, and inspection readiness and management.
• Monitors Quality Assurance, Clinical Operations metrics, reporting, and cross-functional review forums, including the Quality Management Review process.
• Stay current with industry t

Benefits

Additional Information

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas' lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab's unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton's Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody. 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 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/ 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.

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