RxCloud
Website:
therxcloud.com
Job details:
Job Summary
Seasoned Risk-Based Validation Expert with deep expertise in validating Salesforce-based patient services applications (including Salesforce Health Cloud, Life Sciences Cloud, Patient Services Programs, and related custom configurations) in a GxP-regulated pharmaceutical environment.
The role focuses on applying science- and risk-based Computer Software Assurance (CSA) and GAMP 5 principles to ensure patient safety, product quality, data integrity (ALCOA+), and compliance with 21 CFR Part 11, EU Annex 11, HIPAA/GDPR, while enabling agile development and faster releases of patient-facing solutions such as therapy adherence programs, benefit verification, prior authorization automation, care coordination, and patient engagement workflows.
Key Responsibilities
- Conduct GxP impact assessments and risk assessments (using FMEA or similar tools) for Salesforce configurations, custom objects, workflows, integrations, Lightning components, flows, and AI features (e.g., Next Best Action, predictive adherence models) in patient services applications.
- Develop and maintain risk-based validation strategies, Validation Master Plans, and deliverables tailored to Salesforce (leveraging GAMP 5 Category 3/4 systems, supplier documentation, and shared responsibility model).
- Apply FDA Computer Software Assurance (CSA) principles: focus rigorous scripted testing on high-risk functions (e.g., those impacting patient data, adverse event reporting, or therapy access) while using unscripted/exploratory testing, automated testing, and leveraged supplier evidence for lower-risk areas.
- Ensure compliance with data integrity, electronic records/signatures (21 CFR Part 11), audit trails, and security controls (Salesforce Shield, Platform Encryption, Field Audit Trail).
- Manage validation for Salesforce releases, configuration changes, integrations (e.g., with Veeva, ERP, payer systems), and patient services features like benefit verification, co-pay assistance, adherence reminders, and outcomes tracking.
- Support change control, periodic reviews, deviation investigations, and CAPAs for the Salesforce patient services ecosystem.
- Collaborate with Salesforce developers, Patient Services teams, IT, Regulatory Affairs, and Quality to embed risk-based validation into agile/DevOps processes.
- Prepare and defend validation packages during internal audits, FDA/EMA inspections, and client audits.
- Stay current with evolving guidance on cloud/SaaS validation, AI/ML in GxP systems, and continuous validation approaches for dynamic platforms like Salesforce.
Qualifications & Experience
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Computer Science, Engineering, or related field.
- 7–10+ years of experience in Computer System Validation (CSV) or Computer Software Assurance (CSA) within the pharmaceutical or life sciences industry.
- Hands-on experience validating Salesforce platforms (Health Cloud, Life Sciences Cloud, Service Cloud, or custom patient services solutions) in GxP environments.
- Strong working knowledge of:
- GAMP 5 (2nd Edition) for configurable and SaaS systems
- ICH Q9 Quality Risk Management
- FDA CSA Guidance and risk-based testing strategies
- 21 CFR Part 11, EU Annex 11, ALCOA+, HIPAA/GDPR
- Salesforce security, compliance features, and release management
- Proven track record of implementing efficient, right-sized validation that withstands regulatory scrutiny while supporting frequent Salesforce updates and agile delivery.
- Experience with patient services, patient engagement, or commercial pharma applications is highly preferred.
Required Skills & Competencies
- Expertise in risk assessment tools and techniques specific to configurable cloud platforms.
- Proficiency in validation documentation (Validation Plan, Risk Assessment, Traceability Matrix, Test Protocols/Reports) with a focus on value-added, lean documentation.
- Strong understanding of Salesforce architecture, configurations, and integration patterns in regulated settings.
- Excellent critical thinking, scientific justification, and ability to defend risk-based decisions to auditors.
- Experience with test automation, exploratory testing, and tools supporting continuous validation.
- Strong collaboration and communication skills across technical, business, and quality teams.
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