Manager, Quality Operations, CMC
Praxis
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $90,000 - $107,000 per year
Job Level
Mid-LevelSenior
About the role
- Oversee drug substance (DS), drug product (DP), reference standard, and CSPs for clinical and commercial production activities
- Review and approve key strategic product/process documents (e.g., specifications, batch records)
- Support stability program strategy including product shelf life
- Lead, review and approve change controls, deviations, investigations, OOX, CAPA, and Product Quality Complaints
- Perform risk assessment and implement quality and process controls
- Support vendor qualification program and monitor CSP performance
- Develop, maintain, and review clinical and commercial Quality Agreements
- Act as Product Quality Lead in CMC, Program, and CSP team meetings
- Own the APR/PQR, coordinating cross functionally for regulatory requirements
- Direct the disposition (release/reject) activities interfacing with a QP
- Ensure cohesive collaboration across CSPs for timely review of manufacturing records
- Ensure robust processes for product management
- Interface with Regulatory Affairs to review and approve regulatory filings
- Support pre-approval inspection and commercial readiness activities
- Participate in hosting regulatory inspections and internal/external audits
Requirements
- BA or BS degree in Chemistry or related field
- 5+ years in a GMP setting working with clinical and commercial products
- Firsthand experience interpreting and implementing regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA)
- 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 disposition of product batches and interfacing with a QP and CSPs
- Excellent written and oral communication skills
- Must thrive in fast-paced, innovative environment, flexible, proactive, resourceful, and efficient
- Experience with product monitoring, complaint handling, issue resolution preferred
- High level of intellectual curiosity and creative problem solving with entrepreneurial spirit
- Excellent interpersonal skills to develop important relationships that encourage diversity
Benefits
- 99% of premium paid for medical, dental and vision plans
- Company-paid life insurance
- AD&D insurance
- Disability benefits
- Voluntary plans to personalize coverage
- 401(k) matching dollar-for-dollar up to 6%
- Long-term stock incentives
- Employee Stock Purchase Plan (ESPP)
- Discretionary quarterly bonus
- Flexible wellness benefit
- Generous Paid Time Off (PTO)
- Paid holidays
- Company-wide shutdowns
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMPregulatory standardsquality management systemsQC processesregulatory strategyproduct monitoringcomplaint handlingissue resolutionrisk assessmentchange controls
Soft skills
written communicationoral communicationflexibilityproactivityresourcefulnessefficiencyintellectual curiositycreative problem solvinginterpersonal skillsrelationship building