Senior Specialist Complex Investigations

Senior Specialist Complex Investigations

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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.

• Ensure 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.
• Responsible for ensuring investigations present elevated product quality, patient safety, compliance, or regulatory risk are escalated appropriately.

Responsibilities

• Lead the site's most complex and cross-functional deviation investigations.
• Serve as a technical resource for investigations involving complex quality, microbiology, manufacturing, or compliance issues.
• Assemble and lead cross-functional investigation teams through advanced root cause analysis and risk assessment activities.
• Develop and evaluate the effectiveness of implemented corrective and preventive actions.
• Identify systemic opportunities and 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, and associated remediation activities.
• Partner with Quality, Manufacturing, Engineering, Process Development, and Microbiology organizations to ensure timely and compliant investigation closure.
• Develop and maintain metrics that assess investigation quality, effectiveness, and timeliness.
• Drove 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.

Qualifications

• Extensive experience leading complex, cross-functional investigations involving quality systems, manufacturing processes, microbiology, contamination control, or compliance-related issues.
• Demonstrated expertise in 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).
• Demonstrated ability to navigate ambiguity and provide structured, data-driven decision making.
• Demonstrated ability to mentor investigators and influence investigation practices across multiple functional areas.