Senior Specialist Complex Investigations

Amgen SA; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Retirement plan

Medical coverage

Life insurance

Disability coverage

FSAs

Bonus program

Stock incentives

Paid time off

Remote work

Job summary

Amgen is hiring a Senior Specialist for Complex Investigations in North Carolina. You will lead high‑risk, cross‑functional investigations at the Biologics Drug Substance Manufacturing site, partnering with Manufacturing, Quality, Process Development, Engineering, Automation, Microbiology, and site leadership to address critical events.

You will ensure rigorous root‑cause analysis and effective CAPAs while communicating with senior leadership.

Qualifications

• Doctorate or Master’s with related experience in biotech/pharma.
• Experience leading complex investigations with quality systems and compliance focus.
• Strong knowledge of GMP, CAPA, deviation management, and regulatory expectations.

Responsibilities

• Lead the site’s most complex and cross-functional deviation investigations.
• Serve as a technical resource for investigations involving complex quality, microbiology, manufacturing, or compliance issues.
• Assemble and lead cross-functional investigation teams through advanced root-cause analysis and risk assessment activities.
• Apply advanced investigation methodologies including Kepner-Tregoe, Quality Risk Management, 5-Why, Fishbone Analysis, and data-driven problem solving.
• Drive development of robust CAPAs and evaluate the effectiveness of implemented actions.
• Identify systemic opportunities and recurring trends across quality events and drive site-wide improvement initiatives.
• Provide expert technical guidance and coaching to investigators and functional SMEs.
• Present investigation status, findings, risks, and recommendations to site leadership and governance teams.
• Support regulatory inspections and internal audits by presenting investigation strategies, outcomes, and remediation activities.
• Partner with Quality, Manufacturing, Engineering, Process Development, and Microbiology to ensure timely investigation closure.
• Develop and maintain metrics that assess investigation quality, effectiveness, and timeliness.
• Drive continuous improvement of investigation processes, tools, and standards across the site.
• Author and review technically complex investigation reports, risk assessments, and executive summaries.
• Mentor investigators on investigation excellence, technical writing, and root-cause analysis.
• Influence site-wide investigation practices through knowledge sharing and process optimization.

Skills

GMP knowledge

Root-cause analysis

Quality risk management

Investigation leadership

Regulatory inspections

Technical writing

Cross-functional collaboration

Project management

Education

Doctorate

Master's

Bachelor's

Associate's

High school diploma / GED

Tools

Veeva QMS

Job description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over ten million patients worldwide. It’s time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single‑use technologies with traditional stainless‑steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature best‑in‑class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon‑neutral company by 2027.

Senior Specialist – Complex Investigations

What you will do

In this vital role, you will serve as the site expert responsible for leading the most critical, high‑risk, and complex investigations within the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will partner with Manufacturing, Quality, Process Development, Engineering, Automation, Microbiology, and site leadership to investigate significant quality events, recurring deviations, product‑impacting events, and systemic compliance issues.

This position is responsible for ensuring the site’s most consequential investigations are conducted with scientific rigor, thorough root‑cause determination, effective corrective and preventive actions, and clear communication to senior leadership. The role serves as the escalation point for investigations that present elevated product quality, patient safety, compliance, or regulatory risk.

Responsibilities

• Lead the site’s most complex and cross‑functional deviation investigations.
• Serve as a technical resource for investigations involving complex quality, microbiology, manufacturing, or compliance issues.
• Assemble and lead cross‑functional investigation teams through advanced root‑cause analysis and risk assessment activities.
• Apply advanced investigation methodologies including Kepner‑Tregoe, Quality Risk Management, 5‑Why, Fishbone Analysis, and data‑driven problem solving.
• Drive development of robust CAPAs and evaluate the effectiveness of implemented actions.
• Identify systemic opportunities and recurring trends across quality events and drive site‑wide improvement initiatives.
• Provide expert technical guidance and coaching to investigators and functional SMEs.
• Present investigation status, findings, risks, and recommendations to site leadership and governance teams.
• Support regulatory inspections and internal audits by presenting investigation strategies, outcomes, and associated remediation activities.
• Partner with Quality, Manufacturing, Engineering, Process Development, and Microbiology organizations to ensure timely and compliant investigation closure.
• Develop and maintain metrics that assess investigation quality, effectiveness, and timeliness.
• Drive continuous improvement of investigation processes, tools, and standards across the site.
• Author and review technically complex investigation reports, risk assessments, and executive summaries.
• Mentor investigators on investigation excellence, technical writing, and root‑cause analysis.
• Influence site‑wide investigation practices through knowledge sharing, process optimization, and implementation of industry best practices.

Qualifications

What we expect of you

Basic Qualifications

• Doctorate degree & 2 years of directly related experience
• Master's degree & 4 years of directly related experience
• Bachelor's degree & 6 years of directly related experience
• Associate's degree & 10 years of directly related experience
• High school diploma / GED & 12 years of directly related experience

Preferred Qualifications

• 7+ years of biotechnology or pharmaceutical industry experience with progressively increasing responsibility.
• Extensive experience leading complex, cross‑functional investigations involving quality systems, manufacturing processes, microbiology, contamination control, or compliance‑related issues.
• Demonstrated expertise in advanced root‑cause analysis methodologies and quality risk management.
• Strong understanding of GMP regulations, quality systems, deviation management, CAPA systems, and regulatory expectations.
• Experience serving as a lead presenter or SME during regulatory inspections and internal audits.
• Experience using Veeva QMS for investigations and CAPA management.
• Demonstrated ability to influence cross‑functional teams and senior leadership.
• Strong project management and organizational skills.
• Exceptional technical writing and verbal communication skills.
• Degree in Science or Engineering (Microbiology, Biology, Chemical Engineering, Biochemistry, or related discipline preferred).
• Ability to navigate ambiguity and provide structured, data‑driven decision making.
• Demonstrated ability to mentor investigators and influence investigation practices across multiple functional areas.

Benefits

What you can expect of us

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous 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 sales representatives).
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
• Flexible work models, including remote work arrangements where possible.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.