# Sr Auditor, Quality Assurance **Company**: ICON **Location**: Lenexa **Work arrangement**: onsite **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/US-Lenexa-KCIB-PRA/Senior-Auditor--Quality-Assurance_JR162862?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/job/sr-auditor-quality-assurance-37c1c05d-ca5/ ## Description ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. 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. **Responsibilities** - 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 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, 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. **Rewards & Benefits** - Competitive base salary and performance related incentives - Health and wellbeing programmes including medical, dental, and vision coverage where applicable - Retirement and pension plans - Life assurance and disability coverage - Employee assistance programmes and wellbeing resources - Learning and development opportunities through structured training and career pathways For more fresh new jobs, check out [yubhub.co](https://yubhub.co/). ## Skills ### Required - GMP - CMC - ICH-GCP - FDA regulations - Quality Assurance --- Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/US-Lenexa-KCIB-PRA/Senior-Auditor--Quality-Assurance_JR162862?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)