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Job details

Senior Manager, Clinical Quality Audit & Inspection Program

Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders. They are seeking a detail-driven Senior Manager to develop and manage a global GCP/GPvP/GCLP audit and inspection program, lead risk-based audits of trials, vendors, and sites, ensure inspection readiness, manage CAPAs in Veeva QMS, and partner with cross-functional teams to remediate findings and present metrics to senior leadership. The role requires strong regulatory inspection experience and significant travel.

Skills

  • Strong knowledge and application of GCP, GPvP, and GCLP
  • Proven experience in inspection readiness and supporting regulatory inspections (FDA, EMA)
  • Ability to plan and execute risk-based audits of vendors and investigator sites
  • Experience managing CAPAs and audit records in Veeva QMS or similar QMS
  • Excellent audit report writing, presentation, and defense of findings
  • Ability to travel up to 40%–60% and work independently
  • Strong leadership, cross-functional partnering, and continuous improvement skills

Responsibilities

  • Develop SOPs, work instructions, templates, and forms for a fit-for-purpose clinical audit and inspection program
  • Create and execute dynamic, risk-based audit strategies and plans for sponsor processes, systems, trials, sites, and vendors/CSPs
  • Plan, lead, conduct, document, report, and follow up on clinical quality audits per regional regulations and quality agreements
  • Manage audit findings and CAPAs in Veeva QMS; review and approve responses and corrective actions
  • Ensure timely escalation of critical findings and support remediation activities
  • Develop and monitor timeliness and trend metrics for audit findings/CAPAs and present improvement plans to senior management
  • Provide education and guidance on audit processes and inspection readiness
  • Partner with cross-functional stakeholders to ensure consistent audit program implementation

Education

  • Bachelor’s degree in Life Sciences, Engineering, or related field (required)
  • CQA certification (preferred)
  • Advanced degree (MS/PhD) in relevant field (preferred)

Benefits

  • 99% company-paid medical, dental, and vision premiums
  • Company-paid life insurance, AD&D, and disability benefits; voluntary plans available
  • Dollar-for-dollar 401(k) match up to 6%
  • Long-term stock incentives and Employee Stock Purchase Plan (ESPP)
  • Discretionary quarterly bonus and flexible wellness benefit
  • Generous PTO, paid holidays, and company-wide shutdowns
  • Remote flexibility with required travel for role
To read the complete job description, please click on the ‘Apply’ button

Average salary estimate

$132500 / YEARLY (est.)
min
max
$120000K
$145000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

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SENIORITY LEVEL REQUIREMENT
TEAM SIZE
SALARY RANGE
$120,000/yr - $145,000/yr
EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
December 26, 2025
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