Oversee the PFM risk-based Computer System Validation planning and execution (e.g., Validation Plans, Requirements Traceability Matrix, IQ/OQ/PQ, UAT), aligned to 21 CFR Part 11, EU Annex 11, ICH E6(R3) GCP, GLP, and data integrity principles (ALCOA++).
Ensure all computerized systems are validated according to internal SOPs and regulatory expectations.
Maintain a robust risk-based approach to system validation and lifecycle management by assuring periodic review, change control, configuration management, and release readiness for validated systems.
Supports lifecycle controls from implementation through decommissioning.
Establish and enforce QA policies and procedures for PFM systems. Provides input to the Application Development Lifecycle (ADLC) processes to represent regulated technologies
Monitor compliance trends and implement continuous improvement initiatives.
Serve as the primary key liaison with regulatory agencies and third parties for system-related audits and inspections.
Supports the maintenance of inspection ready validation documentation
Partner with Security, Development, PMO, BRM, Business Analysts, DevOps, Clinical Ops, and Lab leaders to prioritize QA activities and embed quality into SDLC/DevOps pipelines
Act as a key liaison with regulatory agencies during inspections related to corporate systems.
Deliver training and coaching on validation, testing, and data integrity for system owners and study teams
Partake to the qualification of data/system service providers
Ensure accurate and timely documentation of validation activities, deviations, and corrective actions.
Provide regular compliance reports and metrics to senior leadership.
Maintain audit readiness for all corporate systems.
Collaboratively work with IT to respond to audit findings.

Requirements

Requires 10 years of experience in clinical research with emphasis in Quality Assurance / Compliance
Strong knowledge of computerized systems validation (CSV)
Experience working on CSV activities in a GxP environment
Strong knowledge of ICH guidelines, 21 CFR Part 11, EU Annex 11 and OECD guidelines.
Supervisory/management experience leading quality personnel
Proven leadership experience managing QA teams and cross-functional projects.
Excellent communication, problem-solving, and organizational skills.
Bachelor’s degree in a science, healthcare or related field of study
Availability to travel up to 25% domestically and/or internationally
Experience leading audits

Benefits

This role is also eligible for a discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation

Applicant Tracking System Keywords

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

Hard Skills & Tools

computerized systems validationvalidation plansrequirements traceability matrixIQ/OQ/PQUATrisk-based approachchange controlconfiguration managementquality assuranceaudit readiness

Soft Skills

leadershipcommunicationproblem-solvingorganizational skillscollaborationtrainingcoaching