Praxis

Compensation

Full Description

Job Description: • Oversee the 3PL contract service providers (CSPs) for commercial production distribution activities. • Review and approve key strategic product/process documents and records. • Support commercial stability program management including trending for early Field Alert Reporting notification. • Support clinical stability program strategy including product shelf life and execution. • Manages mock recall and recall program. • Manages the APR/PQR, coordinating cross functionally to ensure regulatory requirements are met. • Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints. • Performs risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activities. • Ensure cohesive collaboration across CSPs for timely review of GMP records. • Interface with Regulatory Affairs to review, and approve regulatory filings (IND, NDA). • Support pre-approval inspection and commercial readiness activities. • Support or perform internal and external audits. Requirements: • BA or BS degree in Chemistry or related field. • 6+ years in a GMP setting working with clinical and commercial products. • Experience managing stability programs. • Direct experience with recall, APR, FAR management. • Firsthand experience with interpreting and implementing regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA). • Proven ability to operate independently and influence cross-functionally. • Proven track record in supporting regulatory inspections (FDA, EMA). • Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products. • Experience with interfacing with a QP and CSPs. • Excellent written, organizational, and oral communication skills. • Must thrive working in a fast-paced, innovative environment. Benefits: • 99% of the premium paid for medical, dental and vision plans. • Company-paid life insurance, AD&D, disability benefits, and voluntary plans. • 401(k) contributions matched dollar-for-dollar up to 6%. • Long-term stock incentives and ESPP. • Discretionary quarterly bonus. • Flexible wellness benefit. • Generous PTO, paid holidays, and company-wide shutdowns.