Senior Specialist - Investigations & Regulatory Inspections

Summary

Senior Specialist – Investigations & Regulatory InspectionsLiveJob SummaryThis role is a key member of the investigation team for major deviations at the Amgen North Carolina Biologics Drug Substance Manufacturing plant. The incumbent will communicate between GMP manufacturing teams and stakeholder groups, ensure investigations are conducted, documented, and drive improvements in the investigation process.ResponsibilitiesManage complex major deviation investigations, assemble teams, lead root cause analysis, develop CAPAs, and document findings.Partner with manufacturing and inspection readiness teams to prepare for regulatory inspections and internal audits.Coordinate inspection strategy, response development, and war‑room activities during inspections.Author, review, and approve inspection responses, commitments, and remediation plans.Provide consultation on advanced root‑cause analysis and audit readiness.Develop investigation storyboards, inspection narratives, and supporting materials to communicate event history and decisions.Identify gaps, weaknesses, and opportunities for strengthening investigation practices.Drive continuous improvements to investigation processes, quality systems, and inspection readiness programs.Mentor investigators and cross‑functional teams on investigation excellence, technical writing, and regulatory expectations.Communicate progress, risks, and outcomes to impacted areas and senior leadership.QualificationsBasic QualificationsDoctorate and 2 years directly related experience.Master's and 4 years directly related experience.Bachelor's and 6 years directly related experience.Associate's and 10 years directly related experience.High school diploma / GED and 12 years directly related experience.Preferred Qualifications7+ years related work experience in biotech or pharmaceutical industry with progressive responsibility.Expertise leading complex investigations and assessing investigation quality, technical rigor, and regulatory compliance.Experience with compliance, root‑cause analysis, quality risk management, CAPA effectiveness, and quality systems.Degree in Science or Engineering.Deep knowledge of FDA, EMA, and global GMP regulations and inspection expectations.Success 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.Ability to influence senior leadership and drive site‑wide quality initiatives.Mentoring and development of investigators and technical professionals.Excellent written and verbal communication skills.Experience reviewing, authoring, or coaching complex deviation investigations.Experience developing investigation narratives, storyboards, or technical presentations.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.Benefits / What You Can ExpectComprehensive employee benefits package including retirement and savings plan, medical, dental, vision, life, and disability insurance, and flexible spending accounts.Discretionary annual bonus program; sales‑based incentive plan for field sales representatives.Stock‑based long‑term incentives.Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.Flexible work models, including remote work arrangements where possible.Amgen is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.#J-18808-Ljbffr

Job Description

Senior Specialist – Investigations & Regulatory InspectionsLiveJob SummaryThis role is a key member of the investigation team for major deviations at the Amgen North Carolina Biologics Drug Substance Manufacturing plant. The incumbent will communicate between GMP manufacturing teams and stakeholder groups, ensure investigations are conducted, documented, and drive improvements in the investigation process.ResponsibilitiesManage complex major deviation investigations, assemble teams, lead root cause analysis, develop CAPAs, and document findings.Partner with manufacturing and inspection readiness teams to prepare for regulatory inspections and internal audits.Coordinate inspection strategy, response development, and war‑room activities during inspections.Author, review, and approve inspection responses, commitments, and remediation plans.Provide consultation on advanced root‑cause analysis and audit readiness.Develop investigation storyboards, inspection narratives, and supporting materials to communicate event history and decisions.Identify gaps, weaknesses, and opportunities for strengthening investigation practices.Drive continuous improvements to investigation processes, quality systems, and inspection readiness programs.Mentor investigators and cross‑functional teams on investigation excellence, technical writing, and regulatory expectations.Communicate progress, risks, and outcomes to impacted areas and senior leadership.QualificationsBasic QualificationsDoctorate and 2 years directly related experience.Master's and 4 years directly related experience.Bachelor's and 6 years directly related experience.Associate's and 10 years directly related experience.High school diploma / GED and 12 years directly related experience.Preferred Qualifications7+ years related work experience in biotech or pharmaceutical industry with progressive responsibility.Expertise leading complex investigations and assessing investigation quality, technical rigor, and regulatory compliance.Experience with compliance, root‑cause analysis, quality risk management, CAPA effectiveness, and quality systems.Degree in Science or Engineering.Deep knowledge of FDA, EMA, and global GMP regulations and inspection expectations.Success 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.Ability to influence senior leadership and drive site‑wide quality initiatives.Mentoring and development of investigators and technical professionals.Excellent written and verbal communication skills.Experience reviewing, authoring, or coaching complex deviation investigations.Experience developing investigation narratives, storyboards, or technical presentations.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.Benefits / What You Can ExpectComprehensive employee benefits package including retirement and savings plan, medical, dental, vision, life, and disability insurance, and flexible spending accounts.Discretionary annual bonus program; sales‑based incentive plan for field sales representatives.Stock‑based long‑term incentives.Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.Flexible work models, including remote work arrangements where possible.Amgen is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.#J-18808-Ljbffr