Senior Manager Quality Compliance (Rare Disease)
Amgen
August 25, 2026
Remote friendly (United States)
United States
Operations
Quality Compliance Senior Manager
What You Will Do
- Serve as a GCP Subject Matter Expert, providing independent and objective quality advice for clinical trial activities.
- Provide quality oversight for clinical development programs across all stages.
- Plan, conduct, and report risk-based GCP audits (investigator site, affiliate, service provider, and study-level) or support outsourced audits.
- Manage/support regulatory inspections; guide responses to health authorities, including root cause and CAPA plans.
- Provide oversight of the Risk Assessment Categorization Tool (RACT) to identify, prioritize, and mitigate risks to critical data/processes and patient safety, welfare, and rights.
- Support monthly program-level leader meetings to review quality/compliance risks (deviations, trends, filing timelines, potential inspections, other program risks).
- Support response generation for audit findings and self-reported deviations.
- Support regional expertise for quality/compliance with local regulations.
- Conduct risk-based vendor qualifications/evaluations.
- Prepare/analyze data quality indicators and trends; identify gaps; recommend/implement corrective actions; communicate quality metrics.
- Support TA-specific oversight of endpoint technologies (e.g., biomarker usage, imaging methods).
- Support TA-specific risk-based Quality Assurance plans and protocol-specific audit plans (remote or on-site).
- Support Clinical Trial Teams’ quality management activities (Deviations/CAPAs, Serious Breaches/Privacy Issues, inspection readiness/management).
- Implement innovative/proactive quality oversight methodologies (risk-based, analytics using AI/NLP, statistical methods).
- Review clinical trial protocols for simplification, lessons learned, and identification of critical data/processes for risk management.
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 Quality, Operations, and/or Regulatory Compliance (Pharma/Biotech).
Preferred Qualifications
- B.S. in appropriate discipline; advanced degree.
- Quality Assurance qualification/certification.
- 7+ years biopharmaceutical industry Quality/QA (risk-based quality/quality by design).
- 5+ years auditing experience (preferably GCP/GLP/GPvP).
- Experience with regulatory authority inspections and/or pharmacovigilance.
- Leadership/mentoring; QMS experience (e.g., Veeva/Trackwise); strong communication and analytical/decision-making skills.
Application Instructions
- Apply now via careers.amgen.com. No application deadline; applications continue until a sufficient number is received or a candidate is selected.
What You Will Do
- Serve as a GCP Subject Matter Expert, providing independent and objective quality advice for clinical trial activities.
- Provide quality oversight for clinical development programs across all stages.
- Plan, conduct, and report risk-based GCP audits (investigator site, affiliate, service provider, and study-level) or support outsourced audits.
- Manage/support regulatory inspections; guide responses to health authorities, including root cause and CAPA plans.
- Provide oversight of the Risk Assessment Categorization Tool (RACT) to identify, prioritize, and mitigate risks to critical data/processes and patient safety, welfare, and rights.
- Support monthly program-level leader meetings to review quality/compliance risks (deviations, trends, filing timelines, potential inspections, other program risks).
- Support response generation for audit findings and self-reported deviations.
- Support regional expertise for quality/compliance with local regulations.
- Conduct risk-based vendor qualifications/evaluations.
- Prepare/analyze data quality indicators and trends; identify gaps; recommend/implement corrective actions; communicate quality metrics.
- Support TA-specific oversight of endpoint technologies (e.g., biomarker usage, imaging methods).
- Support TA-specific risk-based Quality Assurance plans and protocol-specific audit plans (remote or on-site).
- Support Clinical Trial Teams’ quality management activities (Deviations/CAPAs, Serious Breaches/Privacy Issues, inspection readiness/management).
- Implement innovative/proactive quality oversight methodologies (risk-based, analytics using AI/NLP, statistical methods).
- Review clinical trial protocols for simplification, lessons learned, and identification of critical data/processes for risk management.
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 Quality, Operations, and/or Regulatory Compliance (Pharma/Biotech).
Preferred Qualifications
- B.S. in appropriate discipline; advanced degree.
- Quality Assurance qualification/certification.
- 7+ years biopharmaceutical industry Quality/QA (risk-based quality/quality by design).
- 5+ years auditing experience (preferably GCP/GLP/GPvP).
- Experience with regulatory authority inspections and/or pharmacovigilance.
- Leadership/mentoring; QMS experience (e.g., Veeva/Trackwise); strong communication and analytical/decision-making skills.
Application Instructions
- Apply now via careers.amgen.com. No application deadline; applications continue until a sufficient number is received or a candidate is selected.