Director of Clinical QA

Director of Clinical QA – Bio Space

About The Company

Dren Bio (the "Company") is a privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune and other serious diseases. The Company's management team and scientific advisors have profound expertise covering the discovery and development of specially engineered antibodies. Dren Bio's pipeline encompasses a multitude of programs from its two distinct, wholly‑owned technologies. The Company's lead development candidate, DR‑01, induces antibody‑mediated killing of a specific cell type known to play a key role in various hematologic malignancies and autoimmune disorders.

In addition to DR‑01, the Company has launched multiple programs from its proprietary Targeted Myeloid Engager and Phagocytosis Platform, a bispecific antibody‑based technology that offers a novel mechanism of action focused on selectively engaging myeloid cells (antigen‑presenting cells) for the targeted depletion of pathologic cells and other disease‑causing agents.

This critical position will collaborate with internal clinical and non‑clinical functional groups and external parties including consultants, contract auditors, CRO/Service Provider personnel, and Investigator Sites to promote a high level of quality and consistency across all Dren development programs. The role includes a risk‑based approach to Quality Management for all Dren programs, independent management of domestic and international risk‑based audits of Investigator Sites, clinical vendors, study databases, partners or collaborators (as applicable), and support for internal Dren quality systems with creation, review, and adherence to company policies and procedures and GxP requirements.

• Maintain expert up‑to‑date knowledge on applicable regulations governing the conduct of clinical trials, ICH GCP guidelines and other GxP regulations and industry guidance, and ensure the integration of this information into Quality and Clinical processes.
• Support the development and maintenance of CQA controlled documents and procedures that comply with ICH GCP standards and applicable regulations.
• Create and execute annual audit plan to ensure GCP compliance and adherence to study protocols by vendors, Investigator sites, study databases, and internal clinical team.
• Author and/or review procedures to support the Quality Management System, with emphasis on clinical quality processes, clinical operations and clinical development functions.
• Collaborate with clinical functional groups (e.g., Clinical Operations, Data Management) to provide GCP and regulatory compliance support at the study execution level, including participation as a member of the Clinical Study Execution Team (CSET).
• Perform review of clinical trial documents with a focus on compliance, regulatory requirements and risk (study and company levels) – including Study Protocol and amendments, ICFs, Investigator’s Brochure, Annual Reports (e.g., DSUR), CSRs and other study‑level documents.
• Conduct gap analyses and risk assessments for critical study level activities that may impact subject safety and/or quality and reliability of data.
• Lead or support audits and investigations to evaluate non‑compliance, root‑cause identification, and report results to Dren management; ensure timely completion of comprehensive reports and communication of observations to auditees, impacted functional groups and Dren management.
• Ensure audit corrective and preventive action (CAPA) plans adequately address audit observations and identified root causes, including effectiveness checks where appropriate.
• Provide leadership and support for Inspection Readiness activities and initiatives, and for the preparation, conduct, and response periods of Regulatory Authority Inspections.
• Escalate compliance issues to QA Management and other relevant leadership as needed in a timely manner.
• Develop and/or support GxP tasks or Continuous Improvement initiatives as needed.
• Manage workflow of CQA consultant auditors and, as applicable, manage junior CQA staff.
• Build positive professional…