Senior SpecialistInvestigations & Regulatory Inspections Employer Amgen Location Holly Springs, North Carolina Start date Jul 15, 2026 View more categories View less categories Discipline Regulatory , Regulatory Affairs Required Education High School or equivalent Position Type Full time Hotbed Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, anddeliveringever-better products that reach over10 million patientsworldwide.

Itstime for a career you can be proud of. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior SpecialistInvestigations & Regulatory Inspections Live What youwill do Letsdo this.

Letschange the world. In this vital role, you will be a key member of the team that investigatesmajordeviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams andstakeholder groupsincluding,Process Development,Facilities &Engineering,Automation, EHSS, andQuality. This positionis responsible forensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Responsibilities include:

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. Partnerwith Manufacturing and site inspection readiness teams toprepare forregulatory inspections and internal audits, ensuring manufacturing investigations, records, and supporting documentation areinspection-ready. Coordinate inspection strategy, response development, and war room activities during regulatory inspections. Author, review, and approveinspectionresponses, commitments, and remediation plans. Review, author, and provide consultation on complex deviation investigations to ensure technical rigor, regulatory compliance, andinspectionreadiness. Developinvestigationstoryboards, inspection narratives, and supporting materials that clearly communicate event history, impact assessments, root cause determinations, corrective actions, and productimpactdecisions. Provide an independent audit-readiness perspective on investigations and quality records,identifyingpotential gaps, weaknesses, or areas requiringadditionaltechnical 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 toidentifyopportunities for strengthening investigation practices, quality systems, and inspection readiness. Drive continuous improvements to investigation processes, quality systems, andinspectionreadiness programs. Provide expert consultation and coaching on advanced root cause analysis methodologies. Clearly communicate investigation progress, risks, and outcomes toimpactedareas 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 andmaintainmetrics to assess investigation effectiveness, CAPA effectiveness, andinspectionreadiness. Mentor investigators and cross-functional teams on investigation excellence, technical writing, and regulatory expectations. Win What we expectofyou We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator weseekhas a biologics Drug Substancemanufacturingandinvestigationsbackground with strong cross-functional project management, regulatory presentation experience,and communication skills as well as the below qualifications.

Basic Qualifications :

Doctorate degree&2year ofdirectly relatedexperience Or Masters degree &4years ofdirectly relatedexperience Or Bachelors degreeor &6years ofdirectly relatedexperience Or Associates degree &10years ofdirectly relatedexperience Or High school diploma / GED & 12 years ofdirectly relatedexperience

Preferred Qualifications:

7+ years related work experience (manufacturing,microbiology, process development,or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility Demonstratedexpertiseleading 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, andinspectionreadiness 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, andinspectionreadiness. 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, andinspectionreadiness principles. Ability to work effectively in a matrix environment and build strong cross-functional relationships. Thrive What you can expectofus In addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth and welfare plans for staff and eligible dependents, financial plans with opportunities to savetowards retirement or other goals, work/life balance, and career development opportunities including: 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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 areprovidedreasonable accommodation toparticipatein 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 Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Laboratory Operations Technician, Part-Time Waltham, Massachusetts Senior Manager, Congress Operations Washington D.C., District of Columbia Senior Administrative Assistant, International & State Government Affairs North Chicago, IL