Manager, Quality Operations, CMC
Praxis Precision Medicines, Inc.
August 17, 2026
Remote friendly (Boston, MA)
United States
Operations
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 (specifications, batch records, technical transfer documents, validation protocols/reports, stability documentation, quality agreements).
- Lead assessment and resolution of deviations, OOS/OOT, atypical results, temperature excursions, change controls, CAPAs, and product quality complaints using sound, timely, risk-based decisions.
- Provide Quality oversight of contract manufacturers, laboratories, and other service providers (vendor qualification, audits, performance monitoring, manufacturing record review, issue resolution, follow-up of observations/commitments).
- Lead or support product disposition for clinical and commercial batches (release/reject decisions; coordinate with Qualified Persons where applicable).
- Represent Product Quality on CMC/program/external partner teams; provide strategic input into development, control strategy, technology transfer, process validation, stability, regulatory submissions, and commercialization.
- Partner with CMC, Regulatory Affairs, Supply Chain, and external organizations to anticipate/address quality risks and support IND/NDA filings and regulatory inspections.
Qualifications (Required):
- BA/BS in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or related scientific discipline.
- 6+ years in a GMP-regulated environment supporting clinical and/or commercial pharmaceutical products.
- Strong GMP knowledge and FDA/EMA/ICH and global regulatory expectations; ability to make practical, risk-based decisions.
Preferred/Key Success Factors:
- Experience with small-molecule drug substance and solid oral drug product manufacturing (QMS, QC, technical transfer, validation, stability, lifecycle).
- Hands-on batch disposition, deviations/investigations, change control, CAPA, OOS/OOT, product complaints; Qualified Persons interfacing preferred.
- Inspection/audit experience (health authority, internal, and/or supplier audits).
- Travel ~15–20% domestic/international.
Annualized Base Salary: $117,000–$137,000 USD
- 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 (specifications, batch records, technical transfer documents, validation protocols/reports, stability documentation, quality agreements).
- Lead assessment and resolution of deviations, OOS/OOT, atypical results, temperature excursions, change controls, CAPAs, and product quality complaints using sound, timely, risk-based decisions.
- Provide Quality oversight of contract manufacturers, laboratories, and other service providers (vendor qualification, audits, performance monitoring, manufacturing record review, issue resolution, follow-up of observations/commitments).
- Lead or support product disposition for clinical and commercial batches (release/reject decisions; coordinate with Qualified Persons where applicable).
- Represent Product Quality on CMC/program/external partner teams; provide strategic input into development, control strategy, technology transfer, process validation, stability, regulatory submissions, and commercialization.
- Partner with CMC, Regulatory Affairs, Supply Chain, and external organizations to anticipate/address quality risks and support IND/NDA filings and regulatory inspections.
Qualifications (Required):
- BA/BS in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or related scientific discipline.
- 6+ years in a GMP-regulated environment supporting clinical and/or commercial pharmaceutical products.
- Strong GMP knowledge and FDA/EMA/ICH and global regulatory expectations; ability to make practical, risk-based decisions.
Preferred/Key Success Factors:
- Experience with small-molecule drug substance and solid oral drug product manufacturing (QMS, QC, technical transfer, validation, stability, lifecycle).
- Hands-on batch disposition, deviations/investigations, change control, CAPA, OOS/OOT, product complaints; Qualified Persons interfacing preferred.
- Inspection/audit experience (health authority, internal, and/or supplier audits).
- Travel ~15–20% domestic/international.
Annualized Base Salary: $117,000–$137,000 USD