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Manager, Quality Operations, CMC

5 hours, 50 minutes ago
United States
Full-time
Senior
Operations Manager
Quality Assurance and Testing
Apply Now
Praxis Medicines

Praxis Medicines

Praxis Medicines is focused on translating genetic insights into the development of precision therapies aimed at treating central nervous system disorders characterized by neuronal imbalance, with a commitment to making significant advancements in neur...

Pharmaceuticals
51-250
View All Jobs 6

Description

  • Provide end-to-end product quality oversight for assigned clinical and commercial programs.
  • Review and approve product and process documentation, including specifications, batch records, transfer documents, validation materials, stability documentation, and quality agreements.
  • Lead assessment and resolution of deviations, OOS/OOT results, temperature excursions, change controls, CAPAs, and product quality complaints.
  • Oversee contract manufacturers, laboratories, and service providers through qualification, audits, performance monitoring, and issue follow-up.
  • Lead or support batch disposition activities, including release and reject decisions.
  • Represent Product Quality on CMC, program, and external partner teams.
  • Provide quality input into development, control strategy, technology transfer, process validation, regulatory submissions, and commercialization.
  • Partner with CMC, Regulatory Affairs, Supply Chain, and external organizations to manage quality risks and support inspections and launch readiness.

Requirements

  • 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 global regulatory expectations, including FDA, EMA, and ICH.
  • Experience with small-molecule drug substance and solid oral drug product manufacturing.
  • Experience with Quality Management Systems, QC operations, technical transfer, validation, stability, and product lifecycle management.
  • Hands-on experience with batch disposition, deviations and investigations, change control, CAPA, OOS/OOT events, and product complaints.
  • Experience with external manufacturing partners; experience interfacing with Qualified Persons is strongly preferred.
  • Experience supporting health authority inspections, pre-approval inspections, internal audits, and/or external supplier audits.
  • Ability to travel domestically and internationally, approximately 15–20%.
  • Comfort with regular computer use, clear communication, and occasional movement; reasonable accommodations may be made.

Benefits

  • Remote work with flexibility and willingness to travel as needed.
  • Annualized base salary of $117,000 to $137,000 USD.
  • Equal opportunity employer committed to diversity, equity, and inclusion.
  • Reasonable accommodations available for individuals with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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