Director Clinical Quality Assurance

Pay : $180-240k (depending on experience)

Position Summary

The Director of Clinical Quality will lead the management of GCP quality activities in support of clinical programs and clinical trials. The Director of Clinical Quality will drive proactive quality management while ensuring compliance with corporate policies, procedures, and applicable federal regulations for protection of the rights, welfare, well-being, and personal data privacy of subjects, data integrity, GCP, and FDA regulatory compliance as well as audits strategy. The Director of Clinical Quality will advise on quality management best practices in clinical research and ensure submission ready quality data and first pass approvals by competent authorities for marketing authorization. This position will report to the Quality Head and could be based remotely.

Responsibilities

• Manage Clinical Quality staff and contractors ensuring accountability for deliverables; Ensure staff development and continuous empowerment to increase depth, breadth, and value to the organization.
• Establish and maintain strong working relationships with internal and / or external stakeholders and team leads as assigned.
• Collaborate or guide clinical team on actionable insights during clinical activities execution as appropriate, QA and Clinical Development Operations Leadership and Senior Management.
• Contribute to the planning, management, and performance of GCP audits for clinical trials, e.g internal system / processes and clinical documents or data, including internal CAPA preparation, evaluation and follow up.
• Establish, communicate, execute, and manage BIMO inspection preparation activities to support product commercialization objectives.
• Support the development, implementation and maintenance of QA systems and SOPs for GCP and GLP compliance.
• Represent Clinical Quality Assurance at cross-functional clinical program meetings, and operational activities. Provide appropriate Quality guidance on GCP compliance and continuous improvement matters to internal departments.
• Drive quality improvements and efficiencies along with risk mitigation based on CQA data analysis, operational performance data, knowledge of process.
• Assist with the development, implementation and management of quality oversight plans, tools, and templates.
• Conduct QA reviews of essential documents including as applicable Clinical Protocols, Study Plans / Manuals, Clinical Study Reports, Investigator’s Brochures, for ensuring quality, accuracy and completeness. Lead, implement and maintain GCP QA audit program, which may include qualification, routine and for-cause audits of CROs, investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts. Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness.
• Coordinate GCP training content and delivery for internal employees. Maintain GCP training files within learning management system.
• Actively support the development and deployment of activities to ensure documentation is always audit / inspection ready.
• Report on key metrics (KPIs), quality metrics, periodic quality reports and audits as needed.
• Monitor contractual quality measures (e.g., federal contracts) and assess ability to conform to our own SOPs.
• Maintain current working knowledge of all current applicable regulations.
• Other duties or special projects as assigned or required.

Supervisory Duties

may have up to 1 direct report

Position Qualifications

Specialized Knowledge

Skills

Domestic / International Travel

10-25%

Physical Demands

Should be able to sit at the desk or stand at a computer for prolonged periods.

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