Senior Specialist – Investigations & Regulatory Inspections

About this role

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION?  

If you feel like   you’re   part of something bigger,   it’s   because you are. 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   10 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 not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.  

Senior Specialist   –   Investigations & Regulatory Inspections  

Live   

What you   will do  

Let’s   do this.   Let’s   change the world. In this vital role, you will be a key member of the team that investigates   major   d eviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and   stakeholder groups   including,   Process Development ,   Facilities &   Engineering,   Automation, EHS S, and   Quality . This position   is responsible for   ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.  

Responsibilities include:  

• Manage the site's most complex major deviation investigations, including assembling investigation teams, leading advanced root cause analysis, development of CAPAs, and compliant documentation of findings.  

• Partner   with Manufacturing and site inspection readiness teams to   prepare for   regulatory inspections and internal audits, ensuring manufacturing investigations, records, and supporting documentation are   inspection-ready .  

• Coordinate inspection strategy, response development, and war room activities during regulatory inspections.  

• Author, review, and approve   inspection   responses, commitments, and remediation plans.  

• Review, author, and provide consultation on complex deviation investigations to ensure technical rigor, regulatory compliance, and   inspection   readiness.  

• Develop   investigation   storyboards, inspection narratives, and supporting materials that clearly communicate event history, impact assessments, root cause determinations, corrective actions, and product   impact   decisions.  

• Provide an independent audit-readiness perspective on investigations and quality records,   identifying   potential gaps, weaknesses, or areas requiring   additional   technical justification prior to closure.  

• Partner with Manufacturing teams to prepare subject matter experts for regulatory inspections, internal audits, and quality reviews through coaching, mock interviews, and inspection readiness activities.  

• Evaluate audit observations, inspection feedback, and investigation trends to   identify   opportunities for strengthening investigation practices, quality systems, and inspection readiness.  

• Drive continuous improvements to investigation processes, quality systems, and   inspection   readiness programs.  

• Provide expert consultation and coaching on advanced root cause analysis methodologies.  

• Clearly communicate investigation progress, risks, and outcomes to   impacted   areas and senior leadership.  

• Coordinate and effectively lead cross-functional teams through high-impact investigations and complete milestones on schedule.  

• Present complex technical topics to leadership, auditors, and health authority inspectors.  

• Partner with Quality, Manufacturing, Engineering, Process Development, Automation, and corporate functions to strengthen quality culture and compliance.  

• Develop and   maintain   metrics to assess investigation effectiveness, CAPA effectiveness, and   inspection   readiness.  

• Mentor investigators and cross-functional teams on investigation excellence, technical writing, and regulatory expectations.  

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Win  

What we expect   of   you  

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we   seek   has a biologics Drug Substance   manufacturing   and   investigation s   background with strong cross-functional project management , regulatory presentation experience,   and communication skills as well as the below qualifications.   

Basic Qualifications :  

Doctorate degree   &   2   year of   directly related   experience  

Or   

Master’s degree &   4   years of   directly related   experience    

Or   

Bachelor’s degree   or &   6   years of   directly related   experience    

Or   

Associate’s degree &   10   years of   directly related   experience   

Or  

High school diploma / GED & 12 years of   directly related   experience  

Preferred Qualifications:  

• 7 + years related work experience (manufacturing,   microbiology, process development,   or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility  

• Demonstrated   expertise   leading complex investigations and assessing investigation quality, technical rigor, and regulatory compliance.  

• Extensive experience with compliance, root cause analysis methodologies, quality risk management, CAPA effectiveness, and quality systems.  

• Degree in Science or Engineering.  

• Deep knowledge of FDA, EMA, and global GMP regulations, inspection expectations, and industry best practices related to investigation

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