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← GenScript/ProBio

Head of US Quality Assurance

GenScript/ProBio
Location
Pennington, New Jersey, United States
Posted
1 month ago
Department
ProBio Quality
Salary
$190K - $250K
What they actually want (must-haves)
  • Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related scientific discipline
  • 10+ years of progressive Quality leadership experience in biotechnology, pharmaceutical, or CDMO environments
  • Demonstrated experience in Quality Management Systems (QMS), Quality Operations, and Quality Risk Management
  • Strong experience supporting biologics, plasmid DNA, viral vectors, cell & gene therapy, or other GMP manufacturing operations
  • Extensive knowledge of FDA, EMA, ICH, and global GMP regulations
  • Proven experience leading regulatory inspections and customer audits
Nice to have
  • Advanced degree (M.S. or Ph.D.) preferred
What the job really is

The Head of US Quality Assurance at GenScript's ProBio division is responsible for leading the Quality Assurance organization to ensure compliance with regulatory standards such as FDA and GMP. This role involves overseeing quality systems, managing regulatory inspections, and collaborating with various teams to support project delivery while driving continuous improvement initiatives and developing a high-performing QA team.

Benefits
  • Medical, dental, and vision insurance
  • 401(k) retirement plan with company match that vests fully on day one
  • Paid parental leave after three months of employment
  • Paid time off policy including vacation, personal time, sick time, floating holidays, and company holidays
  • Flexible spending and health savings accounts
  • Life and AD&D insurance
Things to weigh
  • No specific information on the company's culture or work-life balance is provided
  • The role requires extensive experience, which may limit opportunities for less experienced candidates
Job score4.6/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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