Senior Specialist - Investigations & Regulatory Inspections

Senior Specialist – Investigations & Regulatory Inspections

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

• Manage the site's most complex major deviation investigations, assembling investigation teams, leading advanced root‑cause analysis, developing CAPAs, and documenting findings.
• Partner with Manufacturing and site inspection readiness teams to prepare for regulatory inspections and internal audits, ensuring investigations 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 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 lead cross‑functional teams through high‑impact investigations, completing 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.

• Doctorate degree and 2 years of directly related experience.
• Master’s degree and 4 years of directly related experience.
• Bachelor’s degree or 6 years of directly related experience.
• Associate’s degree and 10 years of directly related experience.
• High school diploma / GED and 12 years of directly related experience.

• 7+ years related work experience (manufacturing, microbiology, process development, or quality assurance) 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 management and quality systems.
• Demonstrated success serving as a technical SME during regulatory inspections, internal audits, and inspection readiness activities.
• Experience using Veeva QMS for…