Quality Operations Manager – GMP & Regulatory Readiness

Praxis Precision Medicines, Inc.; Boston (MA); On-site; USD 117,000 - 137,000; Full time

Job summary

Praxis Precision Medicines, Inc. is seeking a Manager, Quality Operations, CMC to lead end-to-end quality for clinical and commercial programs, covering drug substance, drug product, packaging, labeling, serialization, and external manufacturers.

You will review documentation, drive risk-based decisions, and provide strategic Quality input into development and submissions. This remote-friendly leadership role requires strong GMP judgment, ownership, and the ability to ensure launch readiness and

Qualifications

• BA or BS in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or related field.
• 6+ years in GMP-regulated environment for clinical or commercial products.
• Strong GMP knowledge and regulatory expectations (FDA/EMA/ICH).
• Experience with drug substance/product manufacturing, QC, validation, stability, lifecycle management.
• Experience with deviations, investigations, CAPA, OOS/OOT, and vendor oversight.
• Willingness to travel ~15–20% domestically and internationally.

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

GMP experience

Regulatory knowledge

Quality systems

Risk-based decisions

Education

BA/BS in Chemistry/Pharma

Job description

Praxis Precision Medicines, Inc. is seeking a Manager, Quality Operations, CMC to lead end-to-end quality for clinical and commercial programs, covering drug substance, drug product, packaging, labeling, serialization, and external manufacturers.

You will review documentation, drive risk-based decisions, and provide strategic Quality input into development and submissions. This remote-friendly leadership role requires strong GMP judgment, ownership, and the ability to ensure launch readiness and