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← Praxis Precision Medicines, Inc.

Manager, Quality Operations, CMC

Praxis Precision Medicines, Inc.
Location
United States - Remote
Posted
1 month ago
Department
Quality
What they actually want (must-haves)
  • BA or BS in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or a related scientific discipline
  • 6+ years of progressive experience in a GMP-regulated environment supporting clinical and/or commercial pharmaceutical products
  • Strong working knowledge of GMP requirements and applicable FDA, EMA, ICH, and other global regulatory expectations
  • Experience supporting small-molecule drug substance and solid oral drug product manufacturing
  • Hands-on experience with batch disposition, deviations and investigations, change control, CAPA, OOS/OOT events, product complaints, and external manufacturing partners
  • Experience supporting health authority inspections, pre-approval inspections, internal audits, and/or external supplier audits
Nice to have
  • Experience interfacing with Qualified Persons is strongly preferred
What the job really is

The Manager, Quality Operations, CMC is responsible for overseeing product quality throughout the manufacturing and testing processes of Praxis medicines. This role involves collaboration with various departments to ensure compliance with GMP standards and to address quality risks in clinical and commercial programs. The manager will also lead the resolution of quality issues and represent quality interests in cross-functional teams.

Benefits
  • 99% of the premium paid for medical, dental and vision plans
  • Company-paid life insurance, AD&D, disability benefits, and voluntary plans
  • 401(k) matching dollar-for-dollar up to 6% on eligible contributions
  • Long-term stock incentives and ESPP
  • Discretionary quarterly bonus
  • Flexible wellness benefit
Things to weigh
  • Remote position with required travel
  • Role requires strong GMP judgment and comfort operating in ambiguity
  • Focus on building quality into products and processes rather than just inspection
Job score3.4/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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