Manager Quality Intelligence & Strategy

Bion Environmental Technologies Inc

Cambridge, US
Base: $113,600 - $181,600pyear; bonus/equity: annu...
On-site
Global quality assurance oversight framework
Gmp/gdp compliance for mah/sponsor activities
Strategic qa execution across regions
The Manager Quality Intelligence & Strategy is responsible for establishing, implementing, and continuously improving a comprehensive Global Quality Assurance (QA) oversight framework to ensure robust GMP/GDP compliance for Marketing Authorization Holder (MAH) and Sponsor‑related activities across the global pharmaceutical footprint

Job Summary

  • The Manager Quality Intelligence & Strategy is responsible for establishing, implementing, and continuously improving a comprehensive Global Quality Assurance (QA) oversight framework to ensure robust GMP/GDP compliance for Marketing Authorization Holder (MAH) and Sponsor‑related activities across the global pharmaceutical footprint.
  • This role supports improvement projects such as notification management from manufacturing network, Regulatory guidance surveillance and continuous improvement of GMP escalations process.
  • BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce.

Matching Summary

The Manager Quality Intelligence & Strategy is responsible for establishing, implementing, and continuously improving a comprehensive Global Quality Assurance (QA) oversight framework to ensure robust GMP/GDP compliance for Marketing Authorization Holder (MAH) and Sponsor‑related activities across the global pharmaceutical footprint.

Salary

Base: $113,600 - $181,600/year; Bonus/Equity: annual bonus & equity (variable); Benefits: comprehensive benefits package

Skills & Requirements

Must-have

  • Global Quality Assurance oversight framework
  • GMP/GDP compliance for MAH/Sponsor activities
  • Strategic QA execution across regions
  • Continuous improvement of GMP escalations
  • Quality metrics analysis and reporting

Nice-to-have

  • Strong Quality culture promotion
  • Proactive risk identification and mitigation
  • Inspection readiness and subject matter expertise

Key Requirements

  • Bachelor’s degree in Pharmacy, Chemistry, Biology, or related
  • Minimum of 5 years in Quality Assurance, GMP compliance
  • Experience managing MAH/Sponsor responsibilities
  • Knowledge of GMP guidelines, ICH Q10, 21 CFR Part 211
  • Exceptional communication and collaboration skills

Work Rights

Not specified

Tailored Resume

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