Principal Auditor Quality Assurance
MX
PRA Health Sciences
Req #: 121572
Type: Mexico
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Overview: We are currently seeking a Principal Auditor Quality Assurance to join our diverse and dynamic team. As a Principal Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of inNvative treatments and therapies. Responsibilities: What you will be doing * Leading and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines. * Collaborating with cross-functional teams to identify areas for improvement in quality assurance processes and practices. * Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems. * Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements. * Contributing to the continuous improvement of quality assurance programs and initiatives. Qualifications: Your profile * Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. * Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechNlogy, or CRO industry, with at least 3 years in a leadership role. * In-depth kNwledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations). * Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues. * Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.
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