Audit Lead

Pfizer

Remote, United States
Base: $162,900.00 to $271,500.00; bonus: 20.0% of ...
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10 years pharmaceutical industry experience
Aseptic manufacturing expertise required
Gmp/gdp auditing across 3 technology areas
** Pfizer is seeking an Audit Lead for its GMP/GDP audit strategy, focusing on areas such as sterile biologics and medical devices. The role involves overseeing audit processes, ensuring compliance with regulatory expectations, and collaborating with various teams to foster a culture of innovation and quality. **

Job Summary

  • The Audit Lead is responsible for leading the design, delivery, and maintenance of audit strategy for key technology areas including sterile biologics and medical devices.
  • This role requires a minimum of 10 years of progressive experience in the pharmaceutical industry with specific expertise in aseptic manufacturing and GMP/GDP auditing.
  • Candidates are eligible for a base salary ranging from $162,900 to $271,500 plus a 20% bonus target and comprehensive benefits including 401(k) matching.

Matching Summary

Match Score: 75

** Pfizer is seeking an Audit Lead for its GMP/GDP audit strategy, focusing on areas such as sterile biologics and medical devices. The role involves overseeing audit processes, ensuring compliance with regulatory expectations, and collaborating with various teams to foster a culture of innovation and quality. **

Salary

Base: $162,900.00 to $271,500.00; Bonus: 20.0% of base salary; Benefits: 401(k) matching, paid vacation, health coverage

Skills & Requirements

Must-have

  • 10 years pharmaceutical industry experience
  • Aseptic manufacturing expertise required
  • GMP/GDP auditing across 3 technology areas
  • Bachelor's degree in pharmaceutical sciences
  • Knowledge of FDA EU ICH TGA PIC/S ISO standards

Nice-to-have

  • Master's degree in relevant field
  • ASQ recognized audit certification
  • Medical Device Regulations knowledge
  • BoH or Notified Body experience
  • Cross-region audit project leadership

Key Requirements

  • Minimum 10 years experience in pharma/biopharma/medical device
  • Proven GMP/GDP auditing experience in at least 3 technology areas
  • Required Aseptic manufacturing experience
  • Bachelor's degree in pharmaceutical sciences or equivalent
  • Must have permanent US work authorization (no sponsorship)

Work Rights

Permanent work authorization in the United States required

Tailored Resume

Cover Letter