The QA Manager is responsible for ensuring that clinical software applications are developed, and validated in compliance with regulatory standards, Good Clinical Practice (GCP), and company SOPs. The role includes overseeing software testing, managing validation activities, and ensuring the overall quality and reliability of clinical software solutions.
The QA Manager is also responsible for ensuring that Applications Support are in compliance with GCP, SOPs, and regulatory requirements. The role involves overseeing training programs, managing corrective and preventive actions (CAPA), and conducting internal and external audits.
Key Responsibilities
Develop, implement, and maintain robust QMS including SOPs, plans or policies.
Drive continuous improvement in quality processes and systems.
Develop validation plans and protocols in accordance with regulatory requirements and industry best practices.
Oversee the validation activities and maintain thorough and accurate validation documentation, ensuring traceability from requirements to final product release.
Stay updated on regulatory changes and industry standards related to clinical software and inform the team accordingly.
Develop, implement training on QA processes, regulatory requirements, validation procedures and evaluate training programs.
Identify and analyze non-compliance, potential risk, and conduct root cause; Develop, implement and monitor CAPA plan and verify their effectiveness.
Perform internal and external audits to ensure compliance with GCP, SOPs, and regulatory requirements.
Qualifications
Education:
Bachelor’s degree in computer science, software engineering, life sciences, pharmacy, or a related field.
Experience
Minimum of 3 years of experience in quality assurance within clinical software development and validation, or in clinical trial software application support.
Strong understanding of software development lifecycle (SDLC), software testing methodologies, and validation principles.
In-depth knowledge of GCP, regulatory requirements, and clinical trial processes.
Skills
Excellent analytical, problem-solving, and critical thinking skills.
Detail-oriented with strong organizational and documentation skills.
Familiarity with regulatory requirements and standards such as FDA 21 CFR Part 11, GCP or ISO 14155.
Excellent communication and interpersonal abilities.
Employment type
Full-time
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