Senior Specialist – Investigations & Regulatory Inspections
Amgen
August 19, 2026
Remote friendly (Holly Springs, NC)
United States
Operations
Senior Specialist – Investigations & Regulatory Inspections
What You Will Do
- Investigate major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant; ensure investigations are successfully conducted, documented, and improved.
- Manage complex major deviation investigations (lead teams, advanced root cause analysis, develop CAPAs, compliant documentation).
- Partner with Manufacturing and inspection readiness teams to prepare for regulatory inspections and internal audits; ensure investigations/records are inspection-ready.
- Coordinate inspection strategy, inspection responses, and “war room” activities during regulatory inspections.
- Author/review/approve inspection responses, commitments, and remediation plans.
- Review/author/consult on complex deviation investigations for technical rigor, regulatory compliance, and inspection readiness.
- Develop investigation storyboards/narratives to communicate event history, impact, root cause, corrective actions, and product impact decisions.
- Provide independent audit-readiness perspective; identify gaps/weaknesses before closure.
- Coach SMEs for inspections and audits; evaluate trends and observations; drive continuous improvement.
- Lead cross-functional teams, communicate progress/risks/outcomes to leadership, and present complex technical topics.
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 (directly related experience).
Preferred Qualifications
- 7+ years biotech/pharma (manufacturing, microbiology, process development, or QA) with increasing responsibility.
- Expertise in complex investigations, root cause analysis, quality risk management, CAPA effectiveness, and quality systems.
- Knowledge of FDA/EMA/global GMP; experience as a technical SME in inspections/audits.
- Experience with Veeva QMS; strong project/program management; mentoring; excellent written/verbal communication.
Benefits (as stated)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts, annual bonus (or sales incentive plan for field sales), stock-based long-term incentives, time-off plans, bi-annual shutdowns, flexible work models.
Apply now via careers.amgen.com.
What You Will Do
- Investigate major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant; ensure investigations are successfully conducted, documented, and improved.
- Manage complex major deviation investigations (lead teams, advanced root cause analysis, develop CAPAs, compliant documentation).
- Partner with Manufacturing and inspection readiness teams to prepare for regulatory inspections and internal audits; ensure investigations/records are inspection-ready.
- Coordinate inspection strategy, inspection responses, and “war room” activities during regulatory inspections.
- Author/review/approve inspection responses, commitments, and remediation plans.
- Review/author/consult on complex deviation investigations for technical rigor, regulatory compliance, and inspection readiness.
- Develop investigation storyboards/narratives to communicate event history, impact, root cause, corrective actions, and product impact decisions.
- Provide independent audit-readiness perspective; identify gaps/weaknesses before closure.
- Coach SMEs for inspections and audits; evaluate trends and observations; drive continuous improvement.
- Lead cross-functional teams, communicate progress/risks/outcomes to leadership, and present complex technical topics.
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 (directly related experience).
Preferred Qualifications
- 7+ years biotech/pharma (manufacturing, microbiology, process development, or QA) with increasing responsibility.
- Expertise in complex investigations, root cause analysis, quality risk management, CAPA effectiveness, and quality systems.
- Knowledge of FDA/EMA/global GMP; experience as a technical SME in inspections/audits.
- Experience with Veeva QMS; strong project/program management; mentoring; excellent written/verbal communication.
Benefits (as stated)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts, annual bonus (or sales incentive plan for field sales), stock-based long-term incentives, time-off plans, bi-annual shutdowns, flexible work models.
Apply now via careers.amgen.com.