Senior Auditor, Quality Assurance

Sr Auditor, Quality AssuranceICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.Onsite: Lenexa, KSWe are currently seeking a Sr Auditor, Quality Assurance to join our diverse and dynamic team. As a Sr Auditor, Quality Assurance at ICON, you will play a pivotal role in providing quality oversight of GMP/CMC activities supporting clinical trials, interpreting applicable regulatory requirements, and ensuring ongoing compliance, while contributing to the advancement of innovative treatments and therapies.What You Will Be Doing:Serving as the Quality Assurance releasing authority for GMP/CMC activities, including review and disposition of applicable GMP documentation and activities prior to release.Providing dedicated Quality Assurance oversight for GMP operations, including manufacturing, pharmacy, QC laboratory, and other CMC-related activities, as applicable.Reviewing and approving GMP records and quality documentation, including batch records, deviations, investigations, CAPAs, change controls, and other applicable GMP documentation.Ensuring GMP/CMC activities are performed in accordance with applicable GMP requirements, internal quality systems, approved procedures, and client requirements.Providing independent QA guidance and decision-making support for GMP quality and compliance matters, including escalation and resolution of issues that may affect product quality or release.Partnering closely with Manufacturing, Pharmacy Services, QC Lab, and CMC teams to provide proactive QA oversight throughout planning and execution, rather than relying solely on retrospective review.Supporting inspection and audit readiness for GMP/CMC operations and driving continuous improvement of the site quality system.Acting as a key Quality representative for GMP/CMC operations and sponsor interactions related to quality, compliance, and release activities.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.Your profileBachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership role.In-depth knowledge 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.