Remote Senior Director, GMP Quality Assurance

Posted 2 hours ago

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Description:

  • Seeking a Senior Director, GMP Quality Assurance to oversee quality for oncology and rare disease drug discovery projects.
  • Responsible for quality oversight of externally manufactured drug substances and solid oral dose products, including batch disposition and inspection readiness.

Requirements:

  • Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or related field with 15+ years of GMP Quality Assurance experience, including 8+ years in leadership.
  • Extensive experience with outsourced small molecule manufacturing and supporting NDA submissions.
  • Knowledge of regulatory requirements (21 CFR, EU GMP, ICH) and experience with electronic Quality Management Systems.

Benefits:

  • Competitive salary range of $290,469 - $317,518 USD, with bonuses and equity packages.
  • Employer-paid medical, dental, vision insurance, life insurance, and disability coverage.
  • 401(k) plan with company match, flexible vacation, paid parental leave, and tuition assistance.

Job title

Job type

Experience level

Required experience

15 years

Salary

$290,469—$317,518 / year

Degree requirement

Degree required

Skills

-

Location requirements

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