Lead development of the validation strategy within the first 30 days of onboarding
Oversee CSA/CSV compliance execution aligned with the customer SDLC and quality procedures
Provide governance, review, and approval of validation lifecycle deliverables (URS, risk assessments, validation plans, specifications, testing artifacts, traceability, and validation summary)
Ensure readiness for formal testing and completeness of change control documentation
Support CMDB governance and provide guidance on validation and testing tools
Monitor KPI adherence including approval cycle time and traceability coverage

Requirements

8–12+ years in Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
Demonstrated leadership of validation strategy, lifecycle deliverables, and SDLC compliance
Strong experience with SAP or enterprise platform validation in GxP environments
Proven ability to review/approve validation documentation and oversee testing governance
Experience working remotely with global stakeholders
Experience supporting S/4HANA upgrades or large enterprise transformation programs
Familiarity with ALCOA+ documentation principles and quality governance frameworks
Prior lead or architect-level CSA/CSV role

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

Computer System ValidationComputer System Assurancevalidation strategyvalidation lifecycle deliverablesSDLC complianceSAP validationGxP environmentsS/4HANA upgradesALCOA+ documentation principlesquality governance frameworks

Soft Skills

leadershipgovernanceapprovalguidancemonitoringcommunicationcollaborationremote workstakeholder managementoversight