Senior Specialist – Investigations & Regulatory Inspections

About the Role

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX Batch facility in Holly Springs, North Carolina will combine the latest single-use technologies with traditional stainless steel equipment for maximum flexibility. It will also have built-in Industry 4.0 capabilities and sustainability features that support Amgen's plan to be carbon-neutral by 2027.

In this key role, you will be a core member of the team that investigates major deviations at the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will act as the link between the GMP manufacturing teams and other groups, including Process Development, Facilities & Engineering, Automation, EHSS and Quality. You will make sure deviation investigations are carried out and documented properly, and you will drive improvements to the investigation process.

Responsibilities

• Manage the site's most complex major deviation investigations: assemble investigation teams, lead advanced root cause analysis, develop CAPAs and document findings compliantly.
• Work with Manufacturing and site inspection readiness teams to prepare for regulatory inspections and internal audits, keeping investigations, records and supporting documents inspection-ready.
• Coordinate inspection strategy, response development and war room activities during regulatory inspections.
• Author, review and approve inspection responses, commitments and remediation plans.
• Review, author and advise on complex deviation investigations to ensure technical rigor, regulatory compliance and inspection readiness.
• Develop investigation storyboards, inspection narratives and supporting materials.
• Give an independent audit-readiness view on investigations and quality records before they are closed.
• Prepare subject matter experts for regulatory inspections and audits through coaching and mock interviews.
• Evaluate audit observations, inspection feedback and investigation trends.
• Drive continuous improvement of investigation processes, quality systems and inspection readiness programs.
• Provide expert consultation and coaching on advanced root cause analysis methods.
• Communicate investigation progress, risks and outcomes to affected areas and senior leadership.
• Lead cross-functional teams through high-impact investigations.
• Present complex technical topics to leadership, auditors and health authority inspectors.
• Develop and maintain metrics on investigation effectiveness, CAPA effectiveness and inspection readiness.
• Mentor investigators and cross-functional teams.

Basic Qualifications

• Doctorate degree & 2 years of directly related experience, OR
• Master's degree & 4 years of directly related experience, OR
• Bachelor's degree & 6 years of directly related experience, OR
• Associate's degree & 10 years of directly related experience, OR
• High school diploma / GED & 12 years of directly related experience

Preferred Qualifications

• 7+ years of related work experience (manufacturing, microbiology, process development or quality assurance) in the biotech or pharmaceutical industry
• Proven expertise leading complex investigations
• Extensive experience with compliance, root cause analysis, quality risk management, CAPA effectiveness and quality systems
• Degree in Science or Engineering
• Deep knowledge of FDA, EMA and global GMP regulations and inspection expectations
• Proven success as a technical SME during regulatory inspections and audits
• Experience using Veeva QMS for deviations and CAPAs
• Strong project and program management skills
• Excellent written and verbal communication skills
• Ability to work effectively in a matrix environment

Benefits

• Retirement and Savings Plan with generous company contributions
• Medical, dental and vision coverage; life and disability insurance; flexible spending accounts
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans and company-wide shutdowns twice a year
• Flexible work models where possible

Salary Range

$137,263.10 – $185,708.90 USD

Amgen is an Equal Opportunity employer.