Senior Specialist Complex Investigations

BioSpace; Holly Springs (NC); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Flexible work models

Remote work where possible

Job summary

Amgen in North Carolina is seeking a Senior Specialist Complex Investigations to lead the most complex, cross-functional investigations at the Biologics Drug Substance Manufacturing site.

You will partner across Manufacturing, Quality, Process Development, Engineering, and Microbiology to drive RCA, CAPA, and risk assessments with senior leadership, ensuring timely, compliant investigations and strong regulatory communication.

Qualifications

• PhD with related experience required or equivalent.
• Advanced knowledge of quality systems and GMP.
• Experience leading investigations in biotech/pharma settings.
• Strong writing and communication for regulatory interactions.
• Ability to mentor investigators and influence cross-functional teams.

Responsibilities

• Lead the site's most complex, cross-functional investigations.
• Operate as a technical resource for quality, manufacturing and compliance issues.
• Assemble investigation teams for root cause analysis and risk assessment.
• Apply Kepner-Tregoe, 5-Why, Fishbone and data-driven methods.
• Develop robust CAPAs and evaluate action effectiveness.
• Present findings and risk to site leadership and regulators.

Skills

Root cause analysis

Quality systems

GMP knowledge

Regulatory inspections

Cross-functional leadership

Data-driven decision making

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

Veeva QMS

Job description

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, and delivering ever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.

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, and delivering ever-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 Specialist Complex Investigations

Live

What You Will Do

Let'sdo this.Let'schange the world.In this vital role, you will serve as the site expert responsible for leading the most critical, high-risk, and complex investigations within the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will partner with Manufacturing, Quality, Process Development, Engineering, Automation, Microbiology, and site leadership to investigate significant quality events, recurring deviations, product-impacting events, and systemic compliance issues.

This positionis responsible forensuring the site's most consequential investigations are conducted with scientific rigor, thorough root cause determination, effective corrective and preventive actions, and clear communication to senior leadership. The role serves as the escalation point for investigations that present elevated product quality, patient safety, compliance, or regulatory risk.

Responsibilities Include

• Lead the site's most complexand cross-functionaldeviation investigations.
• Servesasa technical resourcefor investigations involvingcomplexquality,microbiology,manufacturing, orcomplianceissues.
• Assemblesand leadscross-functional investigation teams through advanced root cause analysis and risk assessment activities.
• Apply advanced investigation methodologies including Kepner-Tregoe, Quality Risk Management, 5-Why, Fishbone Analysis, and data-driven problem solving.
• Drivedevelopmentof robust CAPAs andevaluate the effectivenessof implemented actions.
• Identifysystemicopportunitiesand recurring trends across quality events and drive site-wide improvement initiatives.
• Provide expert technical guidance and coaching to investigators and functional SMEs.
• Present investigation status, findings, risks, and recommendations to site leadership and governance teams.
• Support regulatory inspections and internal audits by presenting investigation strategies,outcomes, andassociated remediation activities.
• Partner with Quality, Manufacturing, Engineering, Process Development, and Microbiology organizations to ensuretimelyand compliantinvestigationclosure.
• Develop andmaintainmetrics that assessinvestigationquality, effectiveness, and timeliness.
• Drive continuous improvement of investigation processes, tools, and standards across the site.
• Author and review technically complex investigation reports, risk assessments, and executive summaries.
• Mentor investigators on investigation excellence, technical writing, and root cause analysis.
• Influence site-wide investigation practices through knowledge sharing, process optimization, and implementation of industry best practices.

Win

What We Expect Of You

The collaborative investigator weseekhas extensive experience leading complex investigations in a regulated biotechnology or pharmaceutical environment anddemonstratesexceptional technical, analytical, and leadership capabilities.

Basic Qualifications

Doctorate degree &2year ofdirectly relatedexperience

Or

Master's degree &4years ofdirectly relatedexperience

Or

Bachelor's degree &6years ofdirectly relatedexperience

Or

Associate's degree & 10 years ofdirectly relatedexperience

Or

High school diploma / GED & 12 years ofdirectly relatedexperience

Preferred Qualifications

• 7+ years of biotechnology or pharmaceutical industry experience with progressively increasing responsibility.
• Extensive experience leading complex, cross-functional investigations involving quality systems, manufacturing processes, microbiology, contamination control, or compliance-related issues.
• Demonstratedexpertisein advanced root cause analysis methodologies and quality risk management.
• Strong understanding of GMP regulations, quality systems, deviation management, CAPA systems, and regulatory expectations.
• Experience serving as a lead presenter or SME during regulatory inspections and internal audits.
• Experience using Veeva QMS for investigations and CAPA management.
• Demonstrated ability to influence cross-functional teams and senior leadership.
• Strong project management and organizational skills.
• Exceptional technical writing and verbal communication skills.
• Degree in Science or Engineering (Microbiology, Biology, Chemical Engineering, Biochemistry, or related discipline preferred).
• Ability to navigate ambiguity and provide structured, data-driven decision making.
• Demonstrated ability to mentor investigators and influence investigation practices across multiple functional areas.

Thrive

What You Can Expect Of Us

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 save towards 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

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 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.

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