Job Overview
Location
United States - Remote
Job Type
Full-time
Category
Data Science
Date Posted
June 25, 2026
Full Job Description
đź“‹ Description
- • Serve as a GCP Subject Matter Expert, providing independent and objective quality advice to support clinical trial activities in alignment with current best practices.
- • Provide quality oversight for Amgen programs across all stages of clinical development, ensuring compliance with global regulatory standards.
- • Plan, conduct, and report on risk-based GCP audits including investigator site audits, affiliate audits, service provider audits, and study-level audits, or support outsourced audit activities.
- • Manage and support regulatory inspections, providing guidance on responses to health authorities including root cause analysis and CAPA plan development.
- • Oversee the Risk Assessment Categorization Tool (RACT) for each clinical trial to ensure proper identification, prioritization, and mitigation of risks to critical data, patient safety, and rights.
- • Support monthly meetings with clinical program leaders to review quality and compliance risks, including ongoing deviations, quality trends, filing timelines, and potential inspections.
- • Support the generation of responses to audit findings and self-reported deviations, ensuring timely and accurate resolution.
- • Establish and maintain regional expertise to ensure adherence to local regulatory requirements across global operations.
- • Conduct risk-based evaluations and qualifications of new vendors in support of clinical trial activities.
- • Analyze data quality indicators and trends, identify gaps, recommend corrective actions, and communicate key quality metrics to stakeholders on a periodic basis.
- • Support therapeutic area-specific oversight of key technologies, including biomarker usage and imaging methods for endpoint data collection.
- • Develop and implement risk-based, therapeutic area-specific Quality Assurance plans, including protocol-specific audit strategies and execution via remote or on-site methods.
- • Partner with Clinical Trial Teams to manage all quality-related activities, including deviations, CAPAs, serious breaches, privacy issues, inspection readiness, and inspection management.
- • Actively pursue and implement innovative, proactive quality oversight methodologies such as risk-based approaches, data analytics, AI, and Natural Language Processing.
- • Review clinical trial protocols to ensure simplification, application of lessons learned, and identification of critical data and processes for risk management.
- • Maintain current knowledge of regulatory and quality practices, providing continuous training and education to teams.
- • Apply analytical skills to evaluate complex quality issues using qualitative, quantitative, and trend data from multiple sources.
- • Work independently under minimal direction to determine appropriate R&D Quality approaches consistent with therapeutic area programs.
- • Manage multiple concurrent assignments while meeting deadlines for audit reporting and other quality activities.
- • Communicate effectively across local, regional, and global teams.
- • Provide coaching, mentoring, and cross-training to staff in areas of GCP and quality compliance expertise.
- • Support departmental goals through leadership in quality systems, process improvement, and compliance initiatives.
🎯 Requirements
- • Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience in the Pharma/Biotech sector OR Master’s degree and 4 years of experience OR Bachelor’s degree and 6 years of experience OR Associate’s degree and 10 years of experience OR High school diploma/GED and 12 years of experience
- • Thorough knowledge and application of international Good Clinical Practice (GCP) and/or Good Pharmacovigilance Practice (GPvP)
- • Minimum of 7 years in the biopharmaceutical industry in Quality Management, Quality Assurance, or related areas with core responsibility in risk-based quality and quality by design
🏖️ Benefits
- • Comprehensive employee benefits package including Retirement and Savings Plan with company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts
- • Discretionary annual bonus program or sales-based incentive plan for field representatives
- • Stock-based long-term incentives and award-winning time-off plans
- • Flexible work models where possible
Skills & Technologies
See exactly how your profile matches this role — strengths, skill gaps, and what to do about them.
About Amgen Inc.
Amgen Inc. is a global biotechnology company headquartered in Thousand Oaks, California. Founded in 1980, it discovers, develops, manufactures, and delivers human therapeutics targeting cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Using advanced recombinant DNA and molecular biology techniques, Amgen produces biologic medicines such as Neulasta, Enbrel, and Prolia. The company operates R&D, manufacturing, and distribution facilities worldwide, investing heavily in genomic research to identify novel drug targets. Amgen also partners with academic institutions and smaller biotechs to expand its pipeline, aiming to transform breakthrough science into therapies that significantly improve patients’ lives.
Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.
Newsletter
Weekly remote jobs and featured talent.
No spam. Only curated remote roles and product updates. You can unsubscribe anytime.
Similar Opportunities
2 months ago
2 months ago
Hangar Aviation Technologies, Inc.
2 months ago
Singular Intelligence Ltd.
25 days ago