Verista

GxP lifecycle consulting for life sciences

Computer System Assurance Consultant - Multiple Teams

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeKing of Prussia, PA, USARemote

About the Job

Requirements

At least 5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains.
Strong understanding of Computer Software Assurance (CSA) principles, Computer System Validation (CSV), and Software Development Life Cycle (SDLC) processes.
Experience authoring and/or reviewing validation documentation.
Working knowledge of GxP regulations, including FDA, EMA, and ICH requirements, 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.

Responsibilities

Provide CSA and CSV subject matter expertise across Pharmacovigilance, 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, including user requirements specifications, specifications, test plans, and test summaries, in alignment with ALCOA+ and Good Documentation Practices.
Oversee validation readiness and ensure prerequisites are met before 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 to ensure systems remain validated and comply with regulations.
Support periodic review activities, including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance.
Assess the compliance impact of deviations, incidents, corrective and preventive actions, and system issues, ensuring appropriate remediation and documentation.
Review and support vendor documentation, supplier assessments, and software-as-a-service provider quality documentation to support risk-based compliance decisions.
Monitor and evaluate regulatory inspection observations, internal audit findings, and compliance trends to identify opportunities for process improvement.
Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational support.

Desired Qualifications

Experience with enterprise platforms supporting Pharmacovigilance, Clinical, or Regulatory operations.
Prior experience as a Validation subject matter expert, CSA Lead, or Compliance Consultant.
Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms.

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Overview

We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This role will work closely with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures.

Key Responsibilities

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 to ensure continued validated state and ongoing regulatory compliance.
Support periodic review activities including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance.
Assess the compliance impact of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation.
Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation to support risk-based compliance decisions.
Monitor and evaluate regulatory inspection observations, internal audit findings, and compliance trends to identify opportunities for process improvement.
Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational support.

Required Experience & Qualifications

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

Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
Prior role as a Validation SME, CSA Lead, or Compliance Consultant
Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$70,491—$118,062 USD

Benefits

Why Choose Verista?

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

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

For more information about our company, please visit us at Verista.com

National (US) Range 70491 - 118062 USD

About the Company

Verista

GxP lifecycle consulting for life sciences

Verista provides business and technology consulting for life science companies, focusing on systems, compliance, validation and quality across the GxP lifecycle. Its services cover preclinical, clinical, commercialization, manufacturing and distribution to ensure safe, high-quality results. The company combines decades of industry knowledge with advanced engagement platforms and transformative technologies to help clients solve complex challenges with one partner across specialties. With a team of 500+ experts, Verista supports clients from strategy and validation to execution, delivering consistent, compliant outcomes that improve health and lives. The goal is to enable better health outcomes by ensuring products and processes are safe, compliant and efficient throughout the product development lifecycle.

Company size: 201-500
Company stage: Not listed
Total funding: Not listed
Headquarters: Fishers, IN
Founded: 2020

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