Manager, Quality Operations, CMC

The Manager, Quality Operations, CMC is a key quality partner responsible for ensuring that Praxis medicines are manufactured, tested, controlled, released, and maintained to the standards our patients deserve.

This role provides end-to-end Product Quality oversight across clinical development, launch readiness, and commercial operations, with a particular focus on drug substance, drug product, packaging, labeling, and external manufacturing partners. You will work closely with CMC, Regulatory, Supply Chain, and our contract service providers to anticipate risk, solve issues quickly, and build quality into our products and processes and not simply inspect for it afterward.

Success in this role requires strong GMP judgment, comfort operating in ambiguity, and the ability to influence organizational boundaries. We are looking for a builder who takes ownership, asks the hard questions, brings people together around solutions, and balances speed with uncompromising product quality and patient safety.

Primary 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.

Qualifications and Key Success Factors

• 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 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 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. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.