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Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Job Responsibility
Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current best practice
Provide quality oversight for Amgen programs for all stages of products in clinical development
Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits
Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans
Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare, and rights
Support monthly meetings with clinical program level leaders to review quality and compliance related risks, including but not limited to: on-going quality issues/deviations, quality trends, program filing timelines, potential inspections, and risks related to other programs
Support response generation for audit findings and self-reported deviations
Support the establishment of regional expertise to ensure quality and compliance with local regulations
Conduct new vendor qualifications/evaluations in a risk-based manner
Prepare, analyze, and Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other significant quality information on periodic basis to key stakeholders
Support TA-specific oversight of key technologies, including technologies for endpoint data collection and measurement (e.g., biomarker usage and imaging methods)
Support the development of TA-specific Quality Assurance plans that are risk based and efficient
Support Clinical Trial Teams for all quality management activities, including management of quality events (e.g., Deviations/CAPAs, Serious Breaches/Privacy Issues, Inspection Readiness activities, and Inspection Management)
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-based, data analytics that may leverage AI and Natural Language Processing, or other statistically based methods)
Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes for risk management activities
Requirements
Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
Master’s degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
Bachelor’s degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
Associate’s degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
High school diploma / GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
Nice to have
Bachelor of Science degree in appropriate discipline
Advanced degree (e.g., Master’s degree or PhD)
Quality Assurance Qualification/Certification
Minimum of 7 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Minimum of 5 years’ experience as an auditor, preferably in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)