Senior Specialist – Investigations & Regulatory Inspections

Amgen•Holly Springs, NC

About The Position

Amgen is seeking a Senior Specialist – Investigations & Regulatory Inspections for its newest and most advanced drug substance manufacturing plant, the Amgen FleX batch facility. This facility combines the latest in single-use technologies with traditional stainless steel equipment for maximum flexibility. It will feature best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, aligning with Amgen's plan to be a carbon-neutral company by 2027. In this role, you will be a key member of the team investigating major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant, communicating between GMP manufacturing teams and various stakeholder groups. The position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Requirements

Doctorate degree & 2 year of directly related experience
Master’s degree & 4 years of directly related experience
Bachelor’s degree or & 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
Biologics Drug Substance manufacturing and investigations background
Strong cross-functional project management skills
Regulatory presentation experience
Communication skills

Nice To Haves

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 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.

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.
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.