Director of Clinical QA

About the role

This critical position will collaborate with internal clinical and nonclinical 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. This includes a risk-based approach to Quality Management for all Dren programs. Additionally, this position will independently manage domestic and international risk-based audits of Investigator Sites, clinical vendors, study databases, partners or collaborators (as applicable).

Responsibilities

• Provide leadership and support for Inspection Readiness activities and initiatives, and for the preparation, conduct, and response periods of Regulatory Authority Inspections.
• Maintain expert up-to-date knowledge on applicable regulations that govern the conduct of clinical trials, ICH GCP guidelines and other GxP regulations and industry guidance and ensure the information is integrated into Quality and Clinical processes.
• 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 an emphasis on clinical quality processes, clinical operations and clinical development functions.
• Collaborate with clinical functional groups (e.g., Clinical Operations, Data Management, etc.) to provide GCP and regulatory compliance support at the study execution level. This includes Clinical Study Execution Team (CSET) membership and participation.
• Perform review of clinical trial documents with a focus on compliance, regulatory requirements, and risk (study and company levels). The study documents include but are not limited to: Study Protocol and amendments, ICFs, Investigator’s Brochure, Annual Reports (e.g., DSUR), CSRs, and other study level documents (e.g., study plans, subject recruitment materials).
• Conduct gap analyses and risk assessments for critical study level activities that may impact subject safety and/or the 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.
• 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 the workflow of CQA consultant Auditor(s), and as applicable, manage junior CQA staff.
• Build positive professional relationships to support learning, open communication, collaboration, and teamwork.

Qualifications

• 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 of experience in a GCP or CQA quality role, with increasing levels of responsibility.
• Minimum of 5 years’ experience in leading or independently performing CQA audits (Vendor qualification/routine/for-cause, Investigator Site, Gap Assessment, TMF, CSR, etc.), and audit CAPA management.

Skills

• Experience with BIMO inspection, training and preparing company and study sites for inspection readiness
• Knowledge of Computer System Validation requirements in association with CQA audits
• Effective communication skills (written and verbal)
• Ability to build and sustain positive relationships with colleagues, internal stakeholders, and external partners by being transparent, reliable, and delivering on commitments
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
• Ability to create innovative solutions to problems, while integrating stakeholder input and feedback
• Ability to manage multiple priorities and aggressive timelines
• Highly responsible, self-motivated professional with enthusiasm and passion for the company's mission
• Proficient with various Microsoft and other computerized tools: MS Word, Outlook, Excel, PowerPoint, etc.
• Expert knowledge in ICH GCP guidelines and FDA regulations

Benefits

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company’s total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $190,000 and $225,000 per year. At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio’s Human Resources department can share more about the specific pay range based on the market location of the candidate.