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

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.

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GxP systemsCSVCSA principlesSDLC processesvalidation documentationValidation PlansRisk AssessmentsTraceability MatricesValidation Summary ReportsGood Documentation Practices

Soft Skills

strong communication skillsindependent workability to work in fast-paced environmentinterpersonal skills