Senior SpecialistInvestigations & Regulatory Inspections

Overview

Join us at Amgen's newest and most advanced drug substance manufacturing plant in North Carolina. The Amgen FleXbatch facility combines the latest in single use technologies with traditional stainless steel equipment for maximum flexibility in operations. It integrates sustainability innovations to reduce carbon and waste, aligning with Amgen's goal to be carbon-neutral by 2027.

Responsibilities

• 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.
• Career development opportunities including stock-based long-term incentives and award-winning time-off plans.

Qualifications

• Doctorate degree & 2 years of directly related experience
• Masters degree & 4 years of directly related experience
• Bachelor's degree or & 6 years of directly related experience
• Associates degree & 10 years of directly related experience
• High school diploma/GED & 12 years of directly related experience
• 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
• 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 deviation investigations and CAPAs
• Strong project and program management skills
• Experience influencing senior leadership and driving site-wide quality initiatives
• Demonstrated ability to mentor and develop investigators and technical professionals
• Excellent written and verbal communication skills
• Experience reviewing, authoring, or coaching complex deviation investigations to ensure technical rigor, regulatory compliance, and inspection readiness
• Experience developing investigation narratives, storyboards, or technical presentations to effectively communicate quality events during audits and regulatory inspections
• Experience preparing manufacturing personnel and subject matter experts for regulatory inspections, internal audits, or management reviews
• Strong understanding of manufacturing operations, deviation management, CAPA systems, and inspection readiness principles
• Ability to work effectively in a matrix environment and build strong cross-functional relationships