BioSpace
Director of Clinical QA
BioSpace – Dren Bio, a privately held, clinical‑stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune, and other serious diseases.
Dren Bio’s pipeline includes multiple programs built on its proprietary Targeted Myeloid Engager and Phagocytosis Platform, a bispecific antibody technology that selectively engages myeloid cells to deplete pathologic cells.
Role Overview 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 Director of CQA will independently manage domestic and international risk‑based audits of Investigator Sites, clinical vendors, study databases, and partners, and will support internal quality systems with policy creation, review, and adherence to GxP requirements.
Key Responsibilities
Maintain expert, up‑to‑date knowledge of regulations governing clinical trials, ICH GCP guidelines, and other GxP regulations, integrating this information into quality and clinical processes.
Support the development and maintenance of CQA controlled documents and procedures that comply with ICH GCP standards.
Create and execute an annual audit plan to ensure GCP compliance and adherence to study protocols by vendors, investigator sites, study databases, and the internal clinical team.
Author and/or review procedures to support the Quality Management System, emphasizing clinical quality processes.
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 on the Clinical Study Execution Team (CSET).
Perform review of clinical trial documents focusing on compliance, regulatory requirements, and risk, including Study Protocols, ICFs, Investigator’s Brochures, Annual Reports, CSRs, and other study‑level documents.
Conduct gap analyses and risk assessments for critical study‑level activities that may impact subject safety or data quality.
Lead or support audits and investigations to evaluate non‑compliance, identify root causes, and report results to management.
Ensure audit corrective and preventive action (CAPA) plans address observations and root causes, including effectiveness checks where appropriate.
Provide leadership and support for Inspection Readiness activities and initiatives, and for preparation, conduct, and response to regulatory authority inspections.
Escalate compliance issues to QA Management and relevant leadership in a timely manner.
Develop and support GxP tasks or continuous improvement initiatives as needed.
Manage the workflow of CQA consultants and auditors and, as applicable, manage junior CQA staff.
Build positive professional relationships to support learning, open communication, collaboration, and teamwork.
Education, Experience & Qualification Requirements
Minimum of a Bachelor of Science (B.S.) degree in a scientific, life science, or medical/technical discipline.
Minimum of 10 years’ experience within the pharmaceutical industry, with at least 8 years in a GCP or CQA quality role with increasing responsibility.
Minimum of 5 years’ experience leading or independently performing CQA audits (Vendor qualification, Investigator Site, Gap Assessment, TMF, CSR, etc.) and audit CAPA management.
Core Competencies, Knowledge & Skill Requirements
Knowledge of Computer System Validation requirements related to CQA audits.
Effective written and verbal communication skills.
Ability to build and sustain positive relationships with colleagues, internal stakeholders, and external partners.
Ability to influence areas not under direct control to achieve objectives.
Ability to create innovative solutions to problems, integrating stakeholder input.
Ability to manage multiple priorities and aggressive timelines.
Highly responsible, self‑motivated professional with enthusiasm for the company’s mission.
Proficiency with Microsoft tools (Word, Outlook, Excel, PowerPoint) and other computerized tools.
Expert knowledge in ICH GCP guidelines and FDA regulations.
Compensation & Benefits The base pay range for this position upon commencement is expected to be between $190,000 and $225,000 per year. Pay ranges are determined by role, level, and location. Dren Bio offers competitive cash compensation, equity incentive awards, and employer‑sponsored benefits.
Employment Practices Dren Bio is an equal‑opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any applicant for race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by law.
Applications for this role are accepted until the position is filled; please review the posting for the current status.
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Dren Bio’s pipeline includes multiple programs built on its proprietary Targeted Myeloid Engager and Phagocytosis Platform, a bispecific antibody technology that selectively engages myeloid cells to deplete pathologic cells.
Role Overview 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 Director of CQA will independently manage domestic and international risk‑based audits of Investigator Sites, clinical vendors, study databases, and partners, and will support internal quality systems with policy creation, review, and adherence to GxP requirements.
Key Responsibilities
Maintain expert, up‑to‑date knowledge of regulations governing clinical trials, ICH GCP guidelines, and other GxP regulations, integrating this information into quality and clinical processes.
Support the development and maintenance of CQA controlled documents and procedures that comply with ICH GCP standards.
Create and execute an annual audit plan to ensure GCP compliance and adherence to study protocols by vendors, investigator sites, study databases, and the internal clinical team.
Author and/or review procedures to support the Quality Management System, emphasizing clinical quality processes.
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 on the Clinical Study Execution Team (CSET).
Perform review of clinical trial documents focusing on compliance, regulatory requirements, and risk, including Study Protocols, ICFs, Investigator’s Brochures, Annual Reports, CSRs, and other study‑level documents.
Conduct gap analyses and risk assessments for critical study‑level activities that may impact subject safety or data quality.
Lead or support audits and investigations to evaluate non‑compliance, identify root causes, and report results to management.
Ensure audit corrective and preventive action (CAPA) plans address observations and root causes, including effectiveness checks where appropriate.
Provide leadership and support for Inspection Readiness activities and initiatives, and for preparation, conduct, and response to regulatory authority inspections.
Escalate compliance issues to QA Management and relevant leadership in a timely manner.
Develop and support GxP tasks or continuous improvement initiatives as needed.
Manage the workflow of CQA consultants and auditors and, as applicable, manage junior CQA staff.
Build positive professional relationships to support learning, open communication, collaboration, and teamwork.
Education, Experience & Qualification Requirements
Minimum of a Bachelor of Science (B.S.) degree in a scientific, life science, or medical/technical discipline.
Minimum of 10 years’ experience within the pharmaceutical industry, with at least 8 years in a GCP or CQA quality role with increasing responsibility.
Minimum of 5 years’ experience leading or independently performing CQA audits (Vendor qualification, Investigator Site, Gap Assessment, TMF, CSR, etc.) and audit CAPA management.
Core Competencies, Knowledge & Skill Requirements
Knowledge of Computer System Validation requirements related to CQA audits.
Effective written and verbal communication skills.
Ability to build and sustain positive relationships with colleagues, internal stakeholders, and external partners.
Ability to influence areas not under direct control to achieve objectives.
Ability to create innovative solutions to problems, integrating stakeholder input.
Ability to manage multiple priorities and aggressive timelines.
Highly responsible, self‑motivated professional with enthusiasm for the company’s mission.
Proficiency with Microsoft tools (Word, Outlook, Excel, PowerPoint) and other computerized tools.
Expert knowledge in ICH GCP guidelines and FDA regulations.
Compensation & Benefits The base pay range for this position upon commencement is expected to be between $190,000 and $225,000 per year. Pay ranges are determined by role, level, and location. Dren Bio offers competitive cash compensation, equity incentive awards, and employer‑sponsored benefits.
Employment Practices Dren Bio is an equal‑opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any applicant for race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by law.
Applications for this role are accepted until the position is filled; please review the posting for the current status.
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