Lead, Quality Systems Validation – Complaints / Adverse Events

Johnson & Johnson

Lead Quality Systems Validation ensuring compliance and quality for Johnson & Johnson's innovative healthcare solutions. Collaborate globally to integrate quality in project lifecycles while meeting regulatory standards.

Posted 7/14/2026full-timeRaritan • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $94,000 - $151,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computerized System Validation (CSV) within the pharmaceutical and medical device industries, ensuring compliance with cGMP regulations and effective quality management. Proven ability to lead global technology programs and facilitate cross-functional collaboration while maintaining a focus on diversity and inclusion.

Highest-signal resume keywords

Computerized System ValidationCGMP RegulationsLeadership in Global Technology ProgramsValidation Documentation ApprovalCross-Functional Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Computerized System Validation ActivitiesValidation Protocols AuthoringChange Requests ManagementSOPs DevelopmentValidation Plans and ReportsQuality AssuranceQuality EngineeringRegulatory ComplianceRisk-Based Quality ManagementProject Management

Soft Skills

Interdependent PartneringInfluencing SkillsCommunication SkillsSelf-ManagementSolutions Oriented

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryBiotech IndustryHealth Authority InspectionsDiversity and InclusionGlobal Regulatory RequirementsSDLC ValidationGxP SystemsQuality StandardsTechnical Expertise

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Ensure that all J&J quality standards and global regulatory requirements are met
Ensure building and execution activities involve early quality involvement in design and development, integrating quality into work products, implementing controls within applications/solutions, and leveraging automation when feasible
Own the quality approach for systems and hold teams accountable for delivering an end-to-end support model
Provide technical and procedural expertise/guidance to project teams, aligning with internal and external stakeholders
Plan, allocate tasks and resources, execute, coordinate, and maintain validation activities for GxP systems/applications
Support internal audits and Health Authority regulatory inspections
Approve SDLC validation documentation deliverables, including release of system implementations/changes for production
Collaborate with globally diverse teams in an inclusive environment

Requirements

What you’ll need

BS or Equivalent Experience Required
6+ years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required
Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geographies
Demonstrated leadership capabilities fostering diversity and inclusion
Strong skills in interdependent partnering and influencing
Ability to facilitate and communicate key messages and presentations to various cross-functional groups to gain support
Professional Competencies Superior written and oral communication skills
Must have the ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding quality and validation
Solutions oriented, striving for new ways to accomplish goals and pragmatic advising ensuring compliance in a cost-effective and risk-based manner
Ability to manage multiple and competing projects is required
Bachelor's degree in computer science, Information Systems, Business Administration or another related field required.
Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required
Knowledge of Software Quality Assurance and Software Quality Engineering is highly desirable

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.
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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year