Senior Complex Investigations Lead (Biotech)

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

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.