Quality Operations Manager – Remote/Travel

Praxis Precision Medicines, Inc.; United States; Remote; USD 117,000 - 137,000; Full time

Job summary

Praxis Precision Medicines, Inc. invites an experienced Manager, Quality Operations, CMC to join a remote-ready team. You will provide end-to-end product quality oversight across clinical and commercial programs, focusing on drug substance, drug product, packaging, labeling, and external manufacturers.

You will collaborate with CMC, Regulatory, and Supply Chain to anticipate quality risks, drive solutions, and maintain patient safety with rigorous, scalable processes.

Qualifications

• 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 (FDA/EMA/ICH).
• Experience with small-molecule drug substance and solid oral dosage form manufacturing and lifecycle management.
• Hands-on experience with batch disposition, deviations and investigations, change control, CAPA, and external manufacturing partners.
• Ability to travel domestically and internationally, approx. 15–20%.

Responsibilities

• Provide end-to-end Product Quality oversight for clinical and commercial programs across APIs, DP, packaging, labeling, and external partners.
• Review and approve critical product and process documentation including specifications, batch records, and validation reports.
• Lead assessment and resolution of deviations, OOS/OOT, temperature excursions, CAPAs, and product quality complaints with SMEs.
• Provide Quality oversight of contract manufacturers, laboratories, and other service providers, including audits and performance monitoring.
• Lead or support product disposition activities for clinical and commercial batches with Qualified Persons when applicable.
• Represent Product Quality on CMC, program, and external partner teams to influence development, transfer, validation, and regulatory submissions.
• Partner with CMC, Regulatory, Supply Chain and external orgs to anticipate quality risks and support IND/NDA filings and inspections.

Skills

GMP knowledge

Regulatory interpretation

Risk-based decisions

Cross-functional collaboration

Education

BA/BS in Chemistry or related field

Job description

Praxis Precision Medicines, Inc. invites an experienced Manager, Quality Operations, CMC to join a remote-ready team. You will provide end-to-end product quality oversight across clinical and commercial programs, focusing on drug substance, drug product, packaging, labeling, and external manufacturers.

You will collaborate with CMC, Regulatory, and Supply Chain to anticipate quality risks, drive solutions, and maintain patient safety with rigorous, scalable processes.