Senior Specialist – Investigations & Regulatory Inspections

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyou’repart of something bigger,it’sbecause you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, anddeliveringever-better products that reach over10 million patientsworldwide.It’stime 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 Specialist–Investigations & Regulatory Inspections

Live

What youwill do

Let’sdo this.Let’schange 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.

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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 

Master’s degree &4years ofdirectly relatedexperience

Or 

Bachelor’s degreeor &6years ofdirectly relatedexperience

Or 

Associate’s 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.

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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

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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.