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Senior Specialist Quality Assurance, CSV

1 month ago
Anywhere
Full-time
Senior
QA Engineer
DevOps and Infrastructure
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 7

Description

  • Partner cross-functionally with IT and business teams to implement and maintain compliant computerized systems.
  • Provide quality oversight for the lifecycle of computerized systems in alignment with GAMP 5, 21 CFR Part 11, and data integrity standards.
  • Serve as the QA CSV subject matter expert during vendor evaluations, software implementation, and GxP system qualification and requalification.
  • Develop and refine SOPs, training, policies, procedures, and work instructions to support continuous improvement of GxP systems.
  • Ensure SDLC and validation requirements are clearly defined and consistently met.
  • Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis.
  • Review and approve CSV documentation, including validation plans, IQ/OQ/PQ protocols, and summary reports.
  • Advise teams on data integrity best practices and approaches.
  • Partner with IT to maintain inspection readiness for CSV activities.
  • Serve as QA reviewer for new system releases and change controls.
  • Perform internal audits to confirm systems remain in a steady state and user management is controlled.
  • Support AI/ML-enabled GxP systems with validation oversight, risk assessment for model changes, and ongoing performance monitoring.

Requirements

  • 7+ years of experience working in the pharmaceutical or biotech industry.
  • 5+ years of experience with CSV validation lifecycle management.
  • Bachelor’s degree in a life science field.
  • Strong understanding of 21 CFR Part 11/Annex 11 compliance, CSV, CSA, IT SDLC best practices, GDPR, and GAMP 5 guidance.
  • Proven experience supporting validation efforts for SaaS/PaaS GxP systems.
  • Broad understanding of SaaS technology implementation and data migration approaches.
  • Experience validating or assessing AI/ML-based systems in a regulated environment, including model risk and change control considerations.
  • Demonstrated experience reviewing validation deliverables such as user requirements, validation plans, validation reports, and test scripts.

Benefits

  • Base pay range of $101,147.00 to $122,757.00.
  • Additional compensation may include bonus and equity.
  • 100% paid medical, dental, and vision benefits for employees and dependents.
  • 401(k) program with company match and vesting after the first month.
  • Flexible time off.
  • Generous parental leave.
  • Fringe perks and other competitive employee benefits.

Interested in this position?

Apply directly on the company website

Apply Now

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