CMC Quality Operations Manager: GMP & Launch Readiness

Praxis Precision Medicines, Inc.; Northern (KY); Hybrid; USD 117,000 - 137,000; Full time

Job summary

Praxis Precision Medicines is seeking a Manager, Quality Operations, CMC to ensure medicines are manufactured, tested, released, and maintained to the highest standards. You will provide end-to-end quality oversight across clinical development, launch readiness, and commercial operations, focusing on drug substance, drug product, packaging, labeling, and external partners.

Travel will be required; remote work may be possible.

Qualifications

• 6+ years in GMP-regulated environments.
• Experience with small-molecule drug substance and solid oral dosage forms.
• Experience supporting inspections and audits by health authorities.
• Strong GMP judgment and risk-based decision making.
• Ability to travel domestically and internationally (~15–20%).

Responsibilities

• Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, reference standards, packaging, labeling, serialization, and 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 compliance

Quality leadership

Regulatory coordination

Risk-based decisions

Vendor management

Education

BA/BS in Chemistry

Job description

Praxis Precision Medicines is seeking a Manager, Quality Operations, CMC to ensure medicines are manufactured, tested, released, and maintained to the highest standards. You will provide end-to-end quality oversight across clinical development, launch readiness, and commercial operations, focusing on drug substance, drug product, packaging, labeling, and external partners.

Travel will be required; remote work may be possible.