Senior Manager Clinical, Quality Assurance (CQA)
Job Title
Senior Manager Clinical, Quality Assurance (CQA)
Job Status
Full Time
Job mmary
Responsible for ensuring clinical processes within the Drug Development Group are conducted in accordance with corporate SOPs, guidelines and regulations. Develops, performs, and manages clinical quality assurance activities. Presides over clinical audits.
Job Details
- Ensure that all processes contributing to the performance of a clinical trial are conducted properly
- Troubleshoot clinical trials and activities
- Prepare and manage the Drug Development Quality Management Plan including risk management, SOPs, training, regulatory compliance and audit readiness
- Evaluate adequacy of quality assurance standards for the Drug Development Group
- Monitor risk management activities
- Identify training needs and organize training interventions to meet quality standards
- Ensure proper maintenance of clinical trial documentation (e.g., Trial Master Files)
- Create and maintain key documents for the Drug Development Group in compliance with corporate QA standards. Key documents include job descriptions, resumes, SOPs, work instructions, training matrices and training documentation
- Develop and support records management procedures for the Drug Development Group
- Directly interface with Drug Development departments and corporate QA to provide for vendor, site and internal GCP audits
- Perform audit of clinical sites, vendors and CROs, as needed
- Coordinate and support on-site audits conducted by external providers
- Evaluate audit findings and implement appropriate corrective actions
- Support compilation and preparation of Drug Development-related materials for submission to regulatory agencies
- Evaluate quality events, incidents, queries within the Drug Development Group
- Communicate any critical compliance risks noted from these activities to corporate QA and senior management
- Project input and change management for quality improvements affecting CQA
- Preside over improvement programs within the Drug Development Group
- Keep up to date with all related drug development quality legislation and compliance issues
- Utilize guidance documents, international standards, or consensus standards and interpret for guidance
- Draft clinical quality assurance policies and procedures related to the Drug Development Group in accordance with corporate QA policies and standards
- interpret and implement quality assurance standards from corporate QA for the Drug Development Group
Candidate Requirements
- Bachelor’s degree or equivalent combination of education and experience in clinical research
- Certifications an advantage including Quality Auditor, Quality Improvement Associate, Six Sigma
- Quality inspection and auditing experience
- Experience with implementation of corrective action programs
- Drug development industry-specific experience
- Strong computer skills including Microsoft Office, QA applications and databases
- Knowledge of tools, concepts and methodologies of QA
- Knowledge of relevant regulatory requirements
- Attention to detail
- Communication skills – verbal and written
- Data collection, management and analysis
- Problem analysis and problem solving
- Planning and organizing
- Reads, writes and speaks fluent English
Send resume and cover letter to angieprice@elevartherapeutics.com.
