Associate Director, Compliance Operations —investigation Writer

Merck & Co., Inc.

West Point, Pennsylvania, United States
Base: $142,400.00 - $224,100.00; bonus/equity: ann...
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Gmp manufacturing of biologics or vaccines
Writing and closing deviation investigations
Root cause analysis using 5 whys or fishbone
** Merck & Co., Inc. is seeking an experienced Associate Director for Compliance Operations, specifically an investigation writer, to lead investigations of process deviations and ensure regulatory compliance within their Biologics Pilot Plant Operations team. This hybrid position is temporarily based in West Point, PA, with a planned relocation to Rahway, NJ, and requires a strong background in GMP manufacturing and technical writing. **

Job Summary

  • This role requires leading end-to-end investigations across manufacturing operations to determine root causes and ensure compliance with regulatory requirements.
  • The position involves preparing defensible deviation reports and implementing corrective actions while collaborating with cross-functional teams including Manufacturing and Quality.
  • Candidates will support the Next Generation Biologics facility in Rahway, NJ, after an initial 18-24 month assignment in West Point, PA.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking an experienced Associate Director for Compliance Operations, specifically an investigation writer, to lead investigations of process deviations and ensure regulatory compliance within their Biologics Pilot Plant Operations team. This hybrid position is temporarily based in West Point, PA, with a planned relocation to Rahway, NJ, and requires a strong background in GMP manufacturing and technical writing. **

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • GMP manufacturing of biologics or vaccines
  • Writing and closing deviation investigations
  • Root cause analysis using 5 Whys or Fishbone
  • Developing and tracking CAPA effectiveness
  • Technical writing for regulatory submissions
  • Proficiency with Quality Management Systems

Nice-to-have

  • Prior experience as a Deviation Writer
  • Formal training in Six Sigma or RCA
  • Experience supporting regulatory inspections
  • Trend analysis and metrics implementation
  • Influencing skills in matrixed organizations
  • Drafting technical content for inspection packages

Key Requirements

  • Bachelor's degree in scientific discipline with 7 years experience OR Master's with 5 years
  • Minimum 7 years relevant experience in pharmaceutical/biologics/vaccine manufacturing or QA/QC
  • Demonstrated experience in cGMP-regulated environment deviation handling
  • Strong technical writing and editing skills
  • Solid knowledge of FDA, EMA, ICH regulatory expectations

Work Rights

Not specified

Sponsorship: available

Tailored Resume

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