Senior Specialist - Investigations & Regulatory Inspections

Summary

Senior Specialist – Investigations & Regulatory InspectionsIn 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.ResponsibilitiesManage 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.What we expect from youBasic QualificationsDoctorate 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.Preferred Qualifications7+ 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 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.What you can expect from usIn addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work‑life balance, and career development opportunities.Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.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 your 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.#AmgenNorthCarolina#J-18808-Ljbffr

Job Description

Senior Specialist – Investigations & Regulatory InspectionsIn 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.ResponsibilitiesManage 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.What we expect from youBasic QualificationsDoctorate 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.Preferred Qualifications7+ 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 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.What you can expect from usIn addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work‑life balance, and career development opportunities.Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.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 your 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.#AmgenNorthCarolina#J-18808-Ljbffr