Systems Validation Lead
About The Position
The primary role of this position is to assist and guide in project development and implementation of IT applications and initiatives supporting the Foundation’s Information Technology (IT) and Quality Assurance (QA) departments. This position will act as a liaison between Foundation IT and QA, and Foundation divisions (including Skirball Center for Innovation (SCI) and the Clinical Trials Center (CTC)) for project support and new project initiatives. There is a strong focus on medical imaging software/workstations/image transfer platforms and clinical data systems in a highly regulated preclinical and clinical trial environment. The Systems Validation Lead is a key technical and compliance role responsible for overseeing the entire validation lifecycle for GxP-regulated applications used in our clinical research. Reporting primarily to IT with a strong dotted-line relationship to Quality Assurance, this individual will act as the crucial link between technical system implementation and related regulatory compliance needs of the Foundation. Considered the Subject Matter Expert (SME) on Computer System Validation (CSV), the Systems Validation Lead will develop validation strategies, lead execution activities, and ensure organizational and clinical applications (e.g., Medis QAngio, Pie Medical 3Mensio, Philips Ultrasound Workstation) are fit for purpose and maintained in a constant state of control. Extensive, hands-on experience with IQ, OQ, and PQ protocol development, system risk analysis and execution is a foundational requirement for this position.
Requirements
- Bachelor’s degree in a technical or scientific discipline (e.g., Computer Science, Engineering, Biology).
- A minimum of 6 years of direct experience in Computer System Validation (CSV) within a GxP-regulated environment (e.g., healthcare, pharmaceutical, biotechnology, or medical device).
- Expert-level knowledge and proven, hands-on application of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) methodologies.
- Deep understanding of global regulatory requirements and industry best practices, including US 21 CFR Part 11, GAMP 5, and requirements of other applicable jurisdictional regulations.
- Demonstrated experience authoring the full suite of validation documentation (VP, URS, FRS, IQ/OQ/PQ Protocols & Reports, Traceability Matrix, VSR, objective evidence of testing).
- Exceptional technical writing skills with a high degree of accuracy and attention to detail.
- Proven ability to work effectively in a matrixed organization, balancing the needs of technical and quality stakeholders.
Nice To Haves
- Experience in a lead or project management role for validation projects.
- Familiarity with software development lifecycle (SDLC) methodologies.
- Experience participating in or leading vendor/customer audits.
- Professional certifications (e.g., CQA, CSQE) are a plus.
Responsibilities
- Lead risk assessments (e.g., GAMP 5) to define validation scope and testing rigor for new and existing systems.
- Author, review, and approve critical validation lifecycle documents, including Validation Plans (VP) and Validation Summary Reports (VSR).
- Serve as the primary validation SME for internal teams and during regulatory authority inspections (including but not limited to US Food and Drug Administration (FDA), European Medicines Agency (EMA), other applicable jurisdictional authority) and audits of the Foundation.
- Lead the hands-on authoring, review, and execution of comprehensive validation test protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Collaborate with business owners, IT, QA, and functional teams to define and document User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and other specifications as applicable.
- Develop and maintain a Traceability Matrix for each system to ensure all requirements are tested, verified, and thoroughly documented, including maintenance of traceability documentation for version or device upgrades.
- Oversee the resolution of all validation deviations, supporting Foundation QA in documenting investigations and ensuring appropriate corrective actions are implemented.
- Interview Foundation staff as needed to gather and document system validation requirements.
- Act as the primary liaison between IT project teams and the Quality Assurance department, ensuring validation activities align with technical goals, compliance mandates, and project-specific regulatory expectations.
- Manage the change control process for validated systems, performing impact analyses to determine necessary re-validation, regression testing, or additional testing activities.
- Provide expert guidance on 21 CFR Part 11 and Annex 11 requirements, pertaining to the Foundation’s use of electronic records, electronic signatures, and system audit trails.
- Support QA in partnering with vendors to review their validation packages and ensure their systems meet Foundation standards.
- Assist in drafting or updating Foundation procedures and policies related to the implementation and use of systems.
Benefits
- Choice of health plans include medical, Dental, and vision coverage
- Company-paid short-term and long-term disability and life insurance
- Health and dependent care flexible spending accounts
- Pre-tax travel expenses through TransitChek program
- 401(k) plan
- Generous paid time off (PTO)
- Ten paid holidays each year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
