CSA Consultant, PV/Clinical/RA

Job not on LinkedIn

🔥 8 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $70.5k - $118.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

💼 Consultant

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Verista, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏭 Manufacturing

🍽️ Food & Beverage

Consulting • Manufacturing • Food & Beverage

Verista, Inc. is a service provider specializing in solutions for the life sciences, biotech, pharmaceuticals, and medical devices sectors. They offer expertise in areas such as commissioning, qualification, and validation, vision and systems integration, technology solutions, data analytics and strategy, cybersecurity, digital transformation, regulatory compliance, and infrastructure management. Verista excels in providing managed services, program and project management, and digital strategy to ensure quality and compliance throughout the product lifecycle. Their focus on personalized engagement and effective communication makes them a favored partner among top life sciences companies worldwide.

📋 Description

• Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms • Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective • Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports • Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices • Oversee validation readiness and ensure prerequisites are met prior to formal testing • Support change control, configuration management, and release activities • Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance • Provide guidance on CSA-based, risk-driven validation approaches • Conduct periodic system compliance reviews, validation health checks, and lifecycle assessments • Support periodic reviews including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance • Assess compliance impact of deviations, incidents, CAPAs, and system issues, ensuring remediation and documentation • Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation • Monitor regulatory inspection observations, internal audit findings, and compliance trends for process improvement opportunities • Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and operational support

🎯 Requirements

• 5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains • Hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains • Strong understanding of CSA principles, CSV, and SDLC processes • Experience authoring and/or reviewing validation documentation • Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectations • Ability to work independently in a fast-paced, matrixed environment • Strong communication skills and comfort interacting with Quality and business stakeholders • Preferred: Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations • Preferred: Prior role as a Validation SME, CSA Lead, or Compliance Consultant • Preferred: Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms

🏖️ Benefits

• High growth potential and fast-paced organization with a people-focused culture • Competitive pay plus performance-based incentive programs • Company-paid Life, Short-Term, and Long-Term Disability Insurance • Medical, Dental & Vision insurances • FSA, DCARE, Commuter Benefits • Supplemental Life, Hospital, Critical Illness and Legal Insurance • Health Savings Account • 401(k) Retirement Plan (Employer Matching benefit) • Paid Time Off (Rollover Option) and Holidays • As Needed Sick Time • Tuition Reimbursement • Team Social Activities (We have fun!) • Employee Recognition • Employee Referral Program • Paid Parental Leave and Bereavement