Praxis Precision Medicines
Manager, Quality Operations, CMC
RemoteUnited States only
- Experience
- Senior
- Employment
- Full-time
- Company size
- Mid-size
$117k–$137k/yr
Check eligibility
Open to US only. Set where you work from to check your eligibility.
No BS summary
Manager in Product Quality/CMC for small-molecule clinical and commercial programs. Requires 6+ years in GMP-regulated pharma supporting drug substance and solid oral drug product, strong GMP/FDA/EMA/ICH knowledge, and willingness to travel ~15–20%. US-remote role.
Core skills
Product Quality (CMC)
Required skills
GMPFDA/EMA/ICH regulatory knowledgequality management systemsQC operationstechnical transferprocess validationstability documentationbatch dispositiondeviations and investigationschange controlCAPAOOS/OOT investigationvendor qualificationaudit/inspection support
Optional skills
Experience interfacing with Qualified Persons
What you'll do
- 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; coordinate subject matter experts for 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 for inspection and launch readiness.
What they require
- 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%.
Benefits
- Reasonable accommodations for individuals with disabilities (as needed)
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.
$117k–$137k/yr