Senior Specialist, External Capabilities Validation & Compliance (gxp Compliance & Documentation), Pharmaceutical Analysis & Digital Technologies

Merck & Co., Inc.

Rahway, NJ, USA
Base: $106,200.00 - $167,200.00; bonus/equity: ann...
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5+ years pharmaceutical industry experience
Gmp documentation and sop management
Audit and inspection support experience
** Merck & Co., Inc. is seeking a Senior Specialist in External Capabilities Validation & Compliance to enhance GxP compliance and documentation for its global analytical organization. The role requires a strong background in GMP practices, analytical chemistry, and effective collaboration skills. Ideal candidates will have extensive experience in the pharmaceutical industry, particularly in supporting laboratory audits and inspections. **

Job Summary

  • The role involves managing and overseeing GMP documentation, training, and standard operating procedures for a global analytical network.
  • Candidates will lead audit and inspection activities, including preparation, support during inspections, and managing observation responses and CAPAs.
  • The position offers a comprehensive benefits package including medical, dental, vision, retirement benefits, and an annual bonus eligibility.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking a Senior Specialist in External Capabilities Validation & Compliance to enhance GxP compliance and documentation for its global analytical organization. The role requires a strong background in GMP practices, analytical chemistry, and effective collaboration skills. Ideal candidates will have extensive experience in the pharmaceutical industry, particularly in supporting laboratory audits and inspections. **

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays

Skills & Requirements

Must-have

  • 5+ years pharmaceutical industry experience
  • GMP documentation and SOP management
  • Audit and inspection support experience
  • Data integrity deep dive activities
  • Global analytical network oversight

Nice-to-have

  • Experience leading teams for common goals
  • Commitment to diversity and inclusion
  • Innovative problem solving strategies
  • Cross-functional collaboration skills
  • Knowledge of ICH guidelines and CFR requirements

Key Requirements

  • Bachelor's degree in analytical chemistry or related field
  • Minimum 5 years of post-degree relevant industry experience
  • Experience working within a GMP environment
  • US work authorization required (Visa sponsorship available)

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter