Senior Specialist Quality Assurance, CSV
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AI Summary
Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.
Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.
Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.
Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!
The Senior Specialist Quality Assurance, CSV role is responsible for ensuring GxP systems are implemented, validated, and maintained in compliance with regulatory and quality standards. This role partners closely with IT and business teams to support system lifecycle activities, including vendor evaluations, software implementation, and system qualification and requalification.
The QA CSV SME drives risk-based validation processes by establishing and refining policies, procedures, and work instructions, while ensuring Software Development Lifecycle (SDLC) and validation requirements are clearly defined and consistently met. This position reviews and approves validation documentation, provides guidance on data integrity best practices, and serves as the QA lead for system releases and change controls.
Responsibilities:
Partner cross-functionally with IT and the business to implement and maintain compliant computerized systems
Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards
Serve as the QA CSV SME during vendor evaluations, software implementation and qualification and requalification of GxP systems
Support continuous improvement of GxP Systems through SOP development, training, and change control management
Partner with IT and Business teams to ensure SDLC and validation requirements are clearly defined and met
Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis
Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports
Advise on data integrity best practices and approaches
Partner with IT to ensure inspection readiness is maintained for CSV
Serve as QA reviewer for all new system releases and change controls
Perform internal audits to ensure systems are maintained in a steady state and user management is under control
Ensure adherence to regulatory and quality standards throughout the software development lifecycle
Support systems and new product introduction by providing QA expertise, problem solving, and strategies for risk mitigation
Support validation and QA oversight of AI/ML-enabled GxP systems, including risk assessment for model changes and ongoing performance monitoring
Requirements:
- 7+ years experience working in the pharmaceutical/biotech space required
- 5+ years’ experience with CSV validation lifecycle management
- Bachelor’s degree in a life science field
- Excellent understanding of 21 CFR Part 11/Annex 11 compliance and Computer System Validation (CSV), Computer System Assurance (CSA), IT SLDC best practices, General Data Protection Regulation (GDPR) regulations, and GAMP 5 Guidance
- Proven experience in assisting validation efforts for SaaS/PaaS GxP systems
- Broad understanding of Technology implementation (SaaS) and Data migrations approaches
- Experience validating or assessing AI/ML-based systems in a regulated environment, including understanding of model risk and change control considerations
- Demonstrated experience in reviewing key validation deliverables such as user requirements, validation plans, validation reports and test scripts
The starting base pay range for this position is $101,147.00 - $122,757.00 Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
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