Director, Computerized Systems Validation – CSV

Johnson & Johnson

Director managing Computerized Systems Validation at Johnson & Johnson. Ensuring quality standards and regulatory requirements are met across global teams.

Posted 5/22/2026full-timeRaritan • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $150,000 - $258,750 per yearWebsite

Tech Stack

Tools & technologies

CloudCyber SecurityERPPMPSDLC

About the role

Key responsibilities & impact

Ensure that all J&J quality standards and global regulatory requirements are being met.
Ensure that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible.
Provide TQ&C expertise/guidance to the project teams.
Drive the implementation and maintenance of systems to be delivered on time, within budget and with high quality.
Provide end-to-end Technology Quality leadership support to projects and base business support teams across applications and cloud infrastructure.
Lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
Partner with Regional Leads in support of the TQ&C Operating Model.
Lead global teams with unique skills in cross-functional environments.
Provide an environment which encourages the company’s credo and the value of a diverse workforce.
Serve as a trusted partner across the Technology Quality & Compliance organization, requiring collaboration skills at the senior leadership level, both internally and externally.

Requirements

What you’ll need

A Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field is required; Advanced degree is preferred.
10-12 years of experience leading GxP computerized systems validation (CSV) within pharmaceutical, medical device, biotech industry, or other regulated industries.
Deep understanding of GxP regulations and compliance requirements, including data integrity, SDLC governance, validation lifecycle managements, electronic records/signatures, audit trails, and inspection readiness.
Thorough knowledge of global cGMP regulations and computerized systems requirements including: 21 CFR Part 11, 21 CFR Part 210 and 211, 21 CFR Part 820, EU Annex 11, Emerging Annex 22 expectations.
Proven experience providing Quality and Compliance oversight for large scale ERP platform implementations, upgrades, integrations, and lifecycle management activities within regulated environments.
Strong knowledge of ERP ecosystems supporting Finance, Supply Chain, Manufacturing, Procurement, Quality, Warehouse Management, and Planning functions.
Experience leading risk-based validation strategies, and compliance activities for enterprise ERP platforms and supporting digital ecosystems.
Strong experience with Computer System Validation (CSV), Computer Software Assurance (CSA), change control, deviation management, CAPAs, periodic reviews, and validation governance processes.
Experience overseeing validation deliverables and compliance activities associated with ERP implementations including intended use, risk assessments, requirement traceability testing strategies, defect management, and validation summary reporting.
Direct experience supporting regulatory inspection, internal audits, supplier audits, and health authority inspection involving GxP computerized systems and ERP platforms.
Demonstrated people leadership experience managing and developing global, matrixed, and geographically distributed teams.
Experience leading organizational development activities including hiring, performance management, coaching, mentoring, succession planning, talent development, resource management, and organizational capability building.
Strong executive presence with ability to influence and collaborate with senior business, Quality, and technology leaders across global organizations.
Proven experience managing multi-million-dollar platform implementation and operational budgets, including financial planning, forecasting, and cost optimization.
Experience leveraging automation, advanced analytics, AI-enabled technologies, and digital capability to improve validation efficiency, and operational performance.
Understanding of cybersecurity, privacy, and digital risk management principles and their impact on GxP quality systems, validation activities, and regulator technology platforms.
Experience applying security role design, role-based access controls (RBAC), and segregation of duties principles across enterprise technology platforms, and integrated digital ecosystems.
Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), Project Management Professional (PMP) or similar.

Benefits

Comp & perks

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GxP computerized systems validation (CSV)Computer System Validation (CSV)Computer Software Assurance (CSA)risk-based validation strategiesvalidation lifecycle managementERP platform implementationsdata integritySDLC governancechange controldefect management

Soft Skills

people leadershipcollaborationinfluencecoachingmentoringperformance managementorganizational capability buildingtalent developmentresource managementexecutive presence

Certifications

Certified Software Quality Engineer (CSQE)Certified Quality Engineer (SQE)Certified Quality Auditor (SQA)Project Management Professional (PMP)