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Praxis logo
Praxis

Focused patient recruitment.

Senior Manager, Clinical Quality Audit – Inspection Program

ManagerManagerOtherRemoteSeniorTeam 11-50Since 2002H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

171 days ago

Salary

$120K - $145K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishGCP

Job Description

Senior Manager, Clinical Quality Audit – Inspection Program

Praxis

• Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program to ensure compliance with Good Clinical Practice(GCP)/Good Pharmacovigilance Practice(GPvP)/Good Clinical Laboratory Practice (GpLP). • Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and systems, clinical trials, investigator sites, and vendors/contract service providers (CSPs). • Plan, lead, conduct, document, report, and follow-up on clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements. • Ensure appropriate escalation to responsible management for critical audit findings and support. • Provide education and guidance on audit processes and activities. • Manage audit reports, findings, and CAPAs in Veeva Quality Management System (QMS) and review and approve finding responses and actions in system. • Develop and monitor audit finding response and CAPA timeliness performance metrics and present trends and improvement plans to senior management. • Partner with departments across organizations to ensure consistent implementation and execution of audit program. • Work independently with respect to decision making and problem solving.

Job Requirements

  • 10+ years of experience in clinical quality assurance and GCP compliance.
  • Bachelor’s degree in Life Sciences, Engineering, or a related field required; CQA certification is preferred.
  • Strong knowledge and application of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Clinical Laboratory Practice (GCLP).
  • Ability to travel up to 40%-60% of time.
  • Experience conducting audits of vendors and investigative sites.
  • Excellent organizational, written, verbal, and presentation communication skills, including audit report writing, presentation, and defense of findings.
  • Experience in inspection readiness and preparation.
  • Experience hosting and interacting with regulatory authorities.
  • Critical thinking and prioritization skills.
  • Experience managing and being accountable for vendors/contractors and their deliverables.
  • Proven ability to lead cross-functional teams and drive continuous improvement.
  • Proven track record and experience in supporting regulatory inspections (FDA, EMA).

Benefits

  • 99% of the premium paid for medical, dental and vision plans.
  • Company-paid life insurance.
  • AD&D benefits.
  • Disability benefits.
  • Voluntary plans to personalize your coverage.
  • 401(k) matching up to 6% on eligible contributions.
  • Long-term stock incentives.
  • Employee Stock Purchase Program (ESPP).
  • Discretionary quarterly bonus.
  • Flexible wellness benefit.
  • Generous PTO.
  • Paid holidays.
  • Company-wide shutdowns.

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