Note: The job is a remote job and is open to candidates in USA. Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders based on genetic insights. The Manager, Quality Operations, CMC will provide end-to-end Product Quality oversight for clinical and commercial programs, including manufacturing, testing, documentation, batch disposition, external partners, regulatory submissions, and inspection readiness.
Responsibilities
- Provide end-to-end Product Quality oversight for assigned clinical and commercial programs, including drug substance, drug product, reference standards, packaging, labeling, serialization, and associated contract service providers
- Review and approve critical product and process documentation, including specifications, batch records, technical transfer documents, validation protocols and reports, stability documentation, and quality agreements
- Lead the assessment and resolution of deviations, OOS/OOT and other atypical results, temperature excursions, change controls, CAPAs, and product quality complaints; bring together the right subject matter experts to make sound, timely, risk-based decisions
- Provide Quality oversight of contract manufacturers, laboratories, and other service providers, including vendor qualification, audits, performance monitoring, manufacturing record review, issue resolution, and follow-up of observations and commitments
- Lead or support product disposition activities for clinical and commercial batches, including release/reject decisions and coordination with Qualified Persons where applicable
- Represent Product Quality on CMC, program, and external partner teams, providing strategic Quality input into product development, control strategy, technology transfer, process validation, stability, regulatory submissions, and commercialization
- Partner across CMC, Regulatory Affairs, Supply Chain, and external organizations to anticipate and address quality risks, support IND/NDA filings and regulatory inspections, and build scalable processes that enable inspection readiness, launch readiness, and reliable supply to patients
Skills
- 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, with demonstrated ability to translate requirements into practical, risk-based decisions
- Experience supporting small-molecule drug substance and solid oral drug product manufacturing, including 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, product complaints, and external manufacturing partners
- Experience supporting health authority inspections, pre-approval inspections, internal audits, and/or external supplier audits
- Ability to travel domestically and internationally based on program needs, estimated at approximately 15–20%
- The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement
- You'll need comfort with screen work, basic hand coordination, and focus
- Experience interfacing with Qualified Persons is strongly preferred
Benefits
- This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
Company Overview
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