The Director of Quality Assurance leads all aspects of Quality Assurance efforts of CRO activity, development, implementation of CRO Quality Management Systems (QMS) to maintain company and industry best practices with a focus on clinical quality assurance, Good Clinical Practices (GCP) and overall compliance.
- Develop and implement company quality procedures and policies, ensure and maintain industry compliance with applicable regulations, GCP, ICH and other regulatory and compliance requirements.
- Develop and facilitate company training requirements and training programs by department.
- Identify gaps in SOPs and ensure robust procedures are developed, implemented and monitored.
- Contribute to development of applicable SOPs and quality assurance guidance documents and processes.
- Manage the SOP revision and distribution process according to established timelines, guidelines and procedures, including document control standards and electronic filing.
- Develop and maintain company audit plans and schedules.
- Responsible for client audits, vendor selection audits and regulatory inspections.
- Utilize approved QMS systems to identify and address non-compliance trends.
- Library management of paper and electronic documentation, controlled forms.
- Integrate and streamline clinical study partnered services into QMS planning and implementation.
- Communicate cross-functionally with other department leaders to ensure the proper implementation and maintenance of QMS throughout conduct of all clinical studies and associated systems, including Trial Master File (TMF) organization and management.
- Manage and ensure training requirements and records for CRO staff and study teams as appropriate
- Manage company CAPA program by overseeing issue identification, processing, documentation, resolution, and closure.
- Test departmental objectives to ensure alignment with functional and corporate objections.
- Thorough knowledge of drug development, Quality Management Systems (QMS) and processes, FDA regulations, and ICH/GCP guidelines.
- Strong understanding of Quality Assurance practices, systems, and various software platforms
- Knowledge of global regulatory agencies and respective laws and guidelines.
- Proven track record of establishing and management Quality Management Systems.
- Excellent communication skills and demonstrated ability to manage and train direct reports
- Work within and maintain company and departmental budgets
- Ability to lead by example, inspire teamwork, and motivate staff.
- Fluent in English (both written and verbal).
- Excellent computer skills (Microsoft Word, Excel, Outlook, etc.).