Senior Specialist – Investigations & Regulatory Inspections

Career Category

Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyou’repart of something bigger,it’sbecause 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, anddeliveringever-better products that reach over
10 million patients worldwide.

It’stime 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 Fle Xbatch  facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch 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 youwill do

Let’sdo this.

Let’schange the world. In this vital role, you will be a key member of the team that investigatesmajordeviations 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, EHSS, 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 toprepare 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 approveinspectionresponses, commitments, and remediation plans.

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

• Developinvestigationstoryboards, inspection narratives, and supporting materials that clearly communicate event history, impact assessments, root cause determinations, corrective actions, and productimpactdecisions.

• Provide an independent audit-readiness perspective on investigations and quality records,identifying potential gaps, weaknesses, or areas requiringadditionaltechnical 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 toidentifyopportunities for strengthening investigation practices, quality systems, and inspection readiness.

• Drive continuous improvements to investigation processes, quality systems, andinspectionreadiness programs.

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

• Clearly communicate investigation progress, risks, and outcomes toimpactedareas 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…