Manager, Clinical Quality Assurance

Manager, Clinical Quality Assurance

Position: Manager, Clinical Quality Assurance (CQA)

Job Description: We seek a Manager of Clinical Quality Assurance (CQA) to oversee and manage quality system elements, including audit programs, inspection preparation, continuous improvement, and procedural documentation. This role requires interfacing with internal and external stakeholders to ensure compliance with ICH-GCP, cGLP, applicable regulations, and global quality standards.

Key Responsibilities:

• Lead CQA for assigned trials and compliance areas, ensuring timely communication of quality risks and compliance related to GCP/cGLP.
• Develop and execute a risk-based clinical quality audit plan for assigned programs.
• Audit internal processes, clinical investigator sites, and vendors for regulatory compliance and evaluate scientific data accuracy and quality.
• Evaluate the adequacy and completeness of CAPA from audits, deviations, and inspections and perform effectiveness checks.
• Author and manage audit reports and documentation in the QMS.
• Contribute to developing, maintaining, and continuously improving quality system processes, tools, and e-systems.
• Support mock inspections and provide inspection preparation training to internal staff, clinical sites, and vendors.
• Facilitate regulatory agency inspections and related activities.

Basic Qualifications:

• Bachelor’s degree in a scientific field and 3 to 7 years of experience in the pharmaceutical or biotech industry, including 2 to 5 years in Clinical Quality Assurance
• Comprehensive understanding of ICH GCP and applicable CFR regulations, with knowledge of cGLP.
• Experience with risk-based quality management systems and quality by design in Phase I-IV clinical trials.
• Skilled in conducting audits, authoring audit reports, and managing the CAPA process.
• Experience developing SOPs and Work Instructions and reviewing internal processes for accuracy.

Other Requirements:

• Up to 20% travel, primarily within North America and Canada
• Onsite 3 days a week

Join us in ensuring the highest standards of clinical quality and compliance. Apply today to join a dynamic team! Reach out for the complete job description.