Lead Technology Compliance

Johnson & Johnson

Lead Technology Compliance role at Johnson & Johnson focused on global regulatory compliance and audits. Managing compliance programs to drive quality and innovation in healthcare technology.

Posted 7/24/2026full-timeRaritan • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $94,000 - $151,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expert knowledge of Quality System Regulations, ISO, ICH, and cGMP regulations, with a strong focus on compliance in regulated healthcare environments. Proven ability to lead audits, manage regulatory compliance issues, and effectively communicate complex regulatory requirements to stakeholders.

Highest-signal resume keywords

Quality System Regulations ExpertiseGxP Compliance ManagementRegulatory Agency InteractionAudit ManagementAnalytical Mindset

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GxP RegulationsISO StandardsCGMP RegulationsSDLC MethodologiesGAMP5Data Integrity RequirementsAudit PlanningRegulatory Document InterpretationCompliance Metrics AnalysisCorrective Action Implementation

Soft Skills

Excellent Communication SkillsTeam LeadershipInfluencing and NegotiationCross-Functional CollaborationProblem-Solving

Industry Keywords

Healthcare ComplianceRegulatory ComplianceQuality AssuranceAudit ExecutionGlobal Regulatory Agencies

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

execution of closed loop audit and assessment programs , including Technology Supplier Audit and GxP system Periodic Reviews.
providing direct support to business segments during global health authority inspections and other third-party audits related to Technology areas.
compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.
assist in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.
execution of closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, audit and assessment corrective actions, documenting results, reporting on follow-up status, escalating critical issues/risk to senior leadership.
Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers.
Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations.
Works with Quality partners to establish corrective actions to address any identified gaps.
Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs.
Maintain awareness of new and emerging technologies and regulatory requirements.
Participate in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions.
Ensure timely and effective support is provided to J&J Operating Companies globally.
Provides compliance input and final review of formal responses to health authority observations related to Enterprise Quality Compliance Expertise.

Requirements

What you’ll need

A minimum of a Bachelor’s or equivalent University degree is required.
3+ years of progressive experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems and software medical devices.
Auditor experience in a regulated industry, preferably HealthCare Industry.
Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements.
Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.
Experience interpreting regulations and translating regulatory requirements into practical strategies.
Ability to resolve complex regulatory compliance issues.
Ability to analyze and interpret regulatory documents.
Proven experience in driving progress to strategic plans and remaining focused under ambiguous and complex situations.
Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood orally and in writing.
Ability to effectively present information to executive management.
Ability to lead teams and build strong cross-functional relationships.
Ability to influence, negotiate, and build credibility.
Strong skills in interdependent partnering to facilitate collaboration.
Audit management and delivery.
Analytical mindset.

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)).
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