Associate Director, Compliance Operations —investigation Writer

29

West Point, PA, USA
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 fishbone
** The job posting is for an Associate Director of Compliance Operations at a leading biopharmaceutical company, focusing on leading investigations into process deviations and ensuring regulatory compliance. The role requires strong technical writing skills and extensive experience in GMP manufacturing, particularly in biologics or vaccines, with a hybrid work model based in West Point, PA, transitioning to Rahway, NJ. **

Job Summary

  • This role requires leading end-to-end deviation and incident investigations across manufacturing operations to determine root causes and ensure compliance with regulatory requirements.
  • The position involves preparing defensible investigation reports and managing Corrective and Preventive Actions (CAPAs) while collaborating with cross-functional teams including Quality and Manufacturing.
  • Candidates will benefit from a comprehensive benefits package including medical, dental, vision, 401(k), and eligibility for annual bonuses and long-term incentives.

Matching Summary

Match Score: 75

** The job posting is for an Associate Director of Compliance Operations at a leading biopharmaceutical company, focusing on leading investigations into process deviations and ensuring regulatory compliance. The role requires strong technical writing skills and extensive experience in GMP manufacturing, particularly in biologics or vaccines, with a hybrid work model based in West Point, PA, transitioning to Rahway, NJ. **

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 Fishbone
  • Developing and tracking CAPA effectiveness
  • Technical writing for regulatory submissions

Nice-to-have

  • Experience with Six Sigma or RCA certification
  • Supporting regulatory inspections and audits
  • Trend analysis and metrics for continuous improvement
  • Influencing in a matrixed organization
  • Drafting technical content for inspection packages

Key Requirements

  • Bachelor's degree with 7 years experience OR Master's with 5 years
  • Minimum 7 years relevant experience in pharmaceutical/biologics manufacturing
  • Demonstrated experience in cGMP-regulated environment
  • Strong knowledge of FDA, EMA, and ICH regulatory expectations

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter