Senior Specialist – Complex Investigations
Amgen
August 19, 2026
Remote friendly (Holly Springs, NC)
United States
Corporate Functions
Senior Specialist – Complex Investigations
What You Will Do
- Lead the site’s most critical, high-risk, and complex investigations at the Amgen North Carolina Biologics Drug Substance Manufacturing plant.
- Partner cross-functionally (Manufacturing, Quality, Process Development, Engineering, Automation, Microbiology, and site leadership) to investigate significant quality events, recurring deviations, product-impacting events, and systemic compliance issues.
- Ensure investigations use scientific rigor, thorough root cause determination, effective CAPAs, and clear communication to senior leadership; serve as escalation point for elevated product quality, patient safety, compliance, or regulatory risk.
Responsibilities include:
- Lead complex and cross-functional deviation investigations.
- Serve as technical resource for complex quality, microbiology, manufacturing, and compliance issues.
- Assemble and lead cross-functional teams for root cause analysis and risk assessment.
- Apply advanced methodologies (Kepner-Tregoe, Quality Risk Management, 5-Why, Fishbone, data-driven problem solving).
- Develop robust CAPAs and evaluate effectiveness.
- Identify systemic opportunities and recurring trends; drive improvement initiatives.
- Provide technical guidance/coaching; present findings, risks, and recommendations.
- Support regulatory inspections and internal audits with investigation strategies and remediation activities.
- Partner to ensure timely, compliant investigation closure.
- Develop investigation quality/effectiveness/timeliness metrics; continuously improve investigation processes.
- Author/review complex reports, risk assessments, and executive summaries; mentor investigators; influence best practices.
What We Expect Of You
Basic Qualifications:
- Doctorate + 2 years directly related experience; OR Master’s + 4; OR Bachelor’s + 6; OR Associate’s + 10; OR High school/GED + 12.
Preferred Qualifications:
- 7+ years in biotech/pharma with increasing responsibility.
- Experience leading complex cross-functional investigations (quality systems, manufacturing, microbiology, contamination control, compliance).
- Expertise in root cause analysis and quality risk management.
- Strong GMP knowledge; deviation management; CAPA systems; regulatory expectations.
- Lead presenter/SME experience in inspections/audits.
- Veeva QMS experience (investigations/CAPAs).
- Ability to influence senior leadership; strong project management.
- Exceptional technical writing and communication; Science/Engineering degree preferred.
- Ability to navigate ambiguity with structured, data-driven decisions; mentor and influence across functions.
Benefits (if applicable):
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off plans; flexible work models (remote where possible).
Application Instructions:
- Apply now via careers.amgen.com.
What You Will Do
- Lead the site’s most critical, high-risk, and complex investigations at the Amgen North Carolina Biologics Drug Substance Manufacturing plant.
- Partner cross-functionally (Manufacturing, Quality, Process Development, Engineering, Automation, Microbiology, and site leadership) to investigate significant quality events, recurring deviations, product-impacting events, and systemic compliance issues.
- Ensure investigations use scientific rigor, thorough root cause determination, effective CAPAs, and clear communication to senior leadership; serve as escalation point for elevated product quality, patient safety, compliance, or regulatory risk.
Responsibilities include:
- Lead complex and cross-functional deviation investigations.
- Serve as technical resource for complex quality, microbiology, manufacturing, and compliance issues.
- Assemble and lead cross-functional teams for root cause analysis and risk assessment.
- Apply advanced methodologies (Kepner-Tregoe, Quality Risk Management, 5-Why, Fishbone, data-driven problem solving).
- Develop robust CAPAs and evaluate effectiveness.
- Identify systemic opportunities and recurring trends; drive improvement initiatives.
- Provide technical guidance/coaching; present findings, risks, and recommendations.
- Support regulatory inspections and internal audits with investigation strategies and remediation activities.
- Partner to ensure timely, compliant investigation closure.
- Develop investigation quality/effectiveness/timeliness metrics; continuously improve investigation processes.
- Author/review complex reports, risk assessments, and executive summaries; mentor investigators; influence best practices.
What We Expect Of You
Basic Qualifications:
- Doctorate + 2 years directly related experience; OR Master’s + 4; OR Bachelor’s + 6; OR Associate’s + 10; OR High school/GED + 12.
Preferred Qualifications:
- 7+ years in biotech/pharma with increasing responsibility.
- Experience leading complex cross-functional investigations (quality systems, manufacturing, microbiology, contamination control, compliance).
- Expertise in root cause analysis and quality risk management.
- Strong GMP knowledge; deviation management; CAPA systems; regulatory expectations.
- Lead presenter/SME experience in inspections/audits.
- Veeva QMS experience (investigations/CAPAs).
- Ability to influence senior leadership; strong project management.
- Exceptional technical writing and communication; Science/Engineering degree preferred.
- Ability to navigate ambiguity with structured, data-driven decisions; mentor and influence across functions.
Benefits (if applicable):
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off plans; flexible work models (remote where possible).
Application Instructions:
- Apply now via careers.amgen.com.