Quality Systems Manager

The Quality Systems Manager is responsible for supporting GxP compliance across Praxis programs, designing, implementing, and maintaining Quality Systems company-wide, and fostering collaborations across various departments. The ideal candidate will thrive in a results-driven setting with significant potential for impact.

Requirements

• Design, implement, and maintain company-wide stage-appropriate Quality Systems aligned with GxP principles.
• Regularly assess and enhance GxP practices to meet evolving regulations.
• Collaborate with cross-functional teams to drive GxP excellence.
• Provide training on GxP requirements to personnel at all levels.
• Conduct compliance risk assessments, trend analysis, and provide recommendations for compliant business activities.
• Support implementation and training on new quality processes, supporting quality management initiatives.
• Ensure only adequate/approved suppliers and vendors are utilized by the company.
• Establish, compile, track, and present Quality Metrics to support Quality Management Review.
• Support inspection readiness activities, including participation in internal and external audits and regulatory inspections.

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance, AD&D, disability benefits
• Voluntary plans to personalize coverage
• Matching dollar-for-dollar up to 6% on eligible 401(k) contributions
• Long-term stock incentives and ESPP
• Discretionary quarterly bonus
• Extremely flexible wellness benefit
• Generous PTO
• Paid holidays and company-wide shutdowns