Senior Manager Quality Compliance (Rare Disease)
Amgen
June 30, 2026
Remote friendly (United States)
United States
Operations
Quality Compliance Senior Manager
Responsibilities (What You Will Do)
- Serve as a GCP Subject Matter Expert; provide independent, objective quality advice for clinical trial activities.
- Provide quality oversight for Amgen clinical development programs across all stages.
- Plan, conduct, and report risk-based GCP audits (site, affiliate, service provider, study level) or support outsourced audits.
- Manage/support regulatory inspections; guide responses to health authorities, including root cause and CAPA plans.
- Oversee RACT (Risk Assessment Categorization Tool) to ensure risks to critical data/processes and patient safety, welfare, and rights are identified, prioritized, and mitigated.
- Support monthly clinical program leader meetings on quality/compliance risks.
- Support responses to audit findings and self-reported deviations.
- Support establishment of regional quality/compliance expertise for local regulations.
- Conduct risk-based new vendor qualifications/evaluations.
- Prepare/analyze data quality indicators and trends; recommend/implement corrective actions; communicate quality metrics.
- Support TA-specific oversight of key technologies (e.g., endpoint data collection/measurement).
- Support TA-specific risk-based QA plans and protocol-specific audit plans (remote/on-site).
- Support clinical trial teams’ quality management activities (deviations/CAPAs, serious breaches/privacy issues, inspection readiness/management).
- Apply innovative proactive quality oversight methods (e.g., risk-based, data analytics/AI/NLP).
- Review clinical trial protocols for lessons learned and risk management of critical data/processes.
Key Capabilities/Skills
- GCP expertise; analytical, critical-thinking, decision-making; independent work under minimal direction; project management; effective local/regional/global communication; coaching/mentoring.
Knowledge
- Strong understanding of Clinical R&D and global regulations; thorough GCP and/or GPV (required); regulatory submission/inspection management; quality oversight of clinical trials.
Basic Qualifications
- Doctorate + 2 years OR Master’s + 4 years OR Bachelor’s + 6 years OR Associate’s + 10 years OR High school/GED + 12 years in Pharma/Biotech Quality, Operations, and/or Regulatory Compliance.
Preferred Qualifications
- BS; advanced degree; Quality Assurance certification; 7+ years biopharma Quality/QA (risk-based quality/by design); 5+ years as an auditor (preferred GCP/GLP/GPvP); regulatory inspection/other pharmacovigilance experience; leadership/mentoring; QMS/electronic QMS experience (e.g., Veeva/Trackwise); strong business writing/listening; transforming feedback into efficient processes.
Benefits (explicitly listed)
- Retirement and Savings plan, comprehensive medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off; flexible work models where possible.
Application Instructions
- Apply now at careers.amgen.com.
- No application deadline; applications accepted until sufficient candidates are received or a candidate is selected.
- Sponsorship is not guaranteed.
Responsibilities (What You Will Do)
- Serve as a GCP Subject Matter Expert; provide independent, objective quality advice for clinical trial activities.
- Provide quality oversight for Amgen clinical development programs across all stages.
- Plan, conduct, and report risk-based GCP audits (site, affiliate, service provider, study level) or support outsourced audits.
- Manage/support regulatory inspections; guide responses to health authorities, including root cause and CAPA plans.
- Oversee RACT (Risk Assessment Categorization Tool) to ensure risks to critical data/processes and patient safety, welfare, and rights are identified, prioritized, and mitigated.
- Support monthly clinical program leader meetings on quality/compliance risks.
- Support responses to audit findings and self-reported deviations.
- Support establishment of regional quality/compliance expertise for local regulations.
- Conduct risk-based new vendor qualifications/evaluations.
- Prepare/analyze data quality indicators and trends; recommend/implement corrective actions; communicate quality metrics.
- Support TA-specific oversight of key technologies (e.g., endpoint data collection/measurement).
- Support TA-specific risk-based QA plans and protocol-specific audit plans (remote/on-site).
- Support clinical trial teams’ quality management activities (deviations/CAPAs, serious breaches/privacy issues, inspection readiness/management).
- Apply innovative proactive quality oversight methods (e.g., risk-based, data analytics/AI/NLP).
- Review clinical trial protocols for lessons learned and risk management of critical data/processes.
Key Capabilities/Skills
- GCP expertise; analytical, critical-thinking, decision-making; independent work under minimal direction; project management; effective local/regional/global communication; coaching/mentoring.
Knowledge
- Strong understanding of Clinical R&D and global regulations; thorough GCP and/or GPV (required); regulatory submission/inspection management; quality oversight of clinical trials.
Basic Qualifications
- Doctorate + 2 years OR Master’s + 4 years OR Bachelor’s + 6 years OR Associate’s + 10 years OR High school/GED + 12 years in Pharma/Biotech Quality, Operations, and/or Regulatory Compliance.
Preferred Qualifications
- BS; advanced degree; Quality Assurance certification; 7+ years biopharma Quality/QA (risk-based quality/by design); 5+ years as an auditor (preferred GCP/GLP/GPvP); regulatory inspection/other pharmacovigilance experience; leadership/mentoring; QMS/electronic QMS experience (e.g., Veeva/Trackwise); strong business writing/listening; transforming feedback into efficient processes.
Benefits (explicitly listed)
- Retirement and Savings plan, comprehensive medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off; flexible work models where possible.
Application Instructions
- Apply now at careers.amgen.com.
- No application deadline; applications accepted until sufficient candidates are received or a candidate is selected.
- Sponsorship is not guaranteed.