Quality Compliance Manager

As a Quality Compliance Manager at Amgen, you will play a crucial role in providing proactive end-to-end quality support for the development and implementation of a risk-based quality assurance strategy within the General Medicine Therapeutic Area. Your responsibilities will include: - Acting as a GCP Subject Matter Expert to provide independent and objective quality advice for clinical trial activities. - Ensuring quality oversight for all stages of products in clinical development. - Utilizing the Risk Assessment Categorization Tool (RACT) to identify, prioritize, and mitigate risks in trials. - Supporting the establishment of regional expertise to ensure compliance with local regulations. - Assisting Clinical Trial Teams with quality management activities such as Deviations/CAPAs, Inspection Readiness, and Serious Breaches/Privacy Issues. - Reviewing clinical trial protocols, leveraging AI tools for process automation, and managing regulatory inspections. - Identifying data quality indicators/trends, recommending corrective actions, and communicating quality metrics to stakeholders. - Providing Study-Specific Vendor Quality Oversight and conducting risk-based Good Clinical Practices (GCP) audits. To excel in this role, you should have 8-13 years of experience in Quality Management or Quality Assurance within the pharmaceutical/biotech industry, with a focus on risk-based quality and quality by design. You should also possess strong leadership skills, technological literacy, and the ability to understand and articulate technical concepts in English. At Amgen, you can expect vast opportunities for learning, development, and career advancement in a diverse and inclusive environment. Our generous Total Rewards Plan offers healthcare, financial, wealth, and career benefits, along with flexible work arrangements. If you are ready to defy imagination and serve patients above all else, apply now at careers.amgen.com and be a part of a team that is committed to innovation and excellence. Amgen is an equal opportunity employer, dedicated to providing reasonable accommodations for individuals with disabilities throughout the application and employment process. Contact us to request accommodation and join us in our mission to make a difference in the world.,