Company Description ClinFocus is a life sciences organization that specializes in accelerating clinical trials and enhancing data quality through technology-driven solutions. Our services include EDC Development, Systems Integration, AI Deployment & Enablement, Clinical Data Science, Project Management, and Development of Integrated Dashboards. We are an ISO-certified organization and an accredited partner of Medidata Rave, dedicated to delivering excellence and building trust. ClinFocus is seeking an experienced and highly detail-oriented Quality Assurance Manager to lead and enhance our quality management system across all clinical data management and technology services. This critical role will ensure that all processes, deliverables, and systems adhere to regulatory requirements (e.g., FDA, EMA, ICH-GCP), industry best practices, and internal Standard Operating Procedures (SOPs). The Quality Assurance Manager will be instrumental in fostering a culture of quality and continuous improvement throughout the organization. Responsibilities: Develop, implement, and maintain ClinFocus's Quality Management System (QMS) in accordance with applicable regulatory guidelines (e.g., 21 CFR Part 11, ICH-GCP, GAMP 5). Oversee and conduct internal and external audits to ensure compliance with QMS, SOPs, client requirements, and regulatory standards. Manage and lead all quality assurance activities related to clinical data management, EDC system development, data analytics, and other technology solutions. Develop and manage the CAPA (Corrective and Preventive Action) program, ensuring timely investigation, resolution, and effectiveness checks of identified quality issues. Serve as the primary point of contact for client audits and regulatory inspections, facilitating responses and managing follow-up actions. Provide expert guidance and training to staff on quality assurance principles, regulatory requirements, and internal procedures. Review and approve key study documents, including Data Management Plans, Validation Plans, UAT documentation, and programming specifications, from a quality perspective. Participate in vendor qualification and oversight activities, ensuring that third-party services meet ClinFocus's quality standards. Identify opportunities for process improvements and work collaboratively with cross-functional teams to implement efficiencies while maintaining quality. Maintain comprehensive quality metrics and prepare regular reports for management on QMS performance and compliance status. Stay current with evolving regulatory requirements and industry trends in clinical research and data management. Qualifications: Bachelor's or Master's degree in a life science, computer science, or a related field. Minimum of 3 years of progressive experience in Quality Assurance within the pharmaceutical, biotechnology, CRO, or medical device industry In-depth knowledge of global regulatory requirements and industry standards for clinical trials, including ICH-GCP, 21 CFR Part 11, and relevant Annexes to EU GMP. Proven experience in developing, implementing, and managing a QMS. Strong understanding of clinical data management processes, EDC systems (e.g., Medidata Rave), and data integrity principles. Experience with audit management (internal, external, and regulatory inspections). Demonstrated experience with CAPA management. Excellent analytical, problem-solving, and decision-making skills. Exceptional written and verbal communication skills, with the ability to articulate complex quality concepts clearly and concisely. Strong interpersonal skills and the ability to build effective working relationships with internal teams and external clients. Certifications in Quality Assurance (e.g., ASQ Certified Quality Auditor, RAPS Regulatory Affairs Certification) are a plus. Experience with GAMP 5 principles for computerized system validation is highly desirable. What We Offer: The opportunity to play a pivotal role in ensuring the quality and compliance of innovative clinical trial solutions. A collaborative and supportive environment where your expertise is valued. Opportunities for professional growth and leadership development. Competitive compensation and benefits package. Show more Show less
