Director, Technical Quality – Compliance

Johnson & Johnson

. Provide strategic leadership for Medical Device Regulatory activities .

Posted 9/24/2026full-timeUnited StatesLead💰 $150,000 - $258,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Medical Device Regulatory activities, ensuring compliance with GxP regulations and quality standards throughout the product lifecycle. Proven ability to lead cross-functional teams and drive quality system transformation in highly regulated environments.

Highest-signal resume keywords

GxP Computerized Systems Validation (CSV)Global cGMP RegulationsQuality System TransformationTechnical Quality & Compliance LeadershipRegulatory Certifications (ASQ, RAC)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data IntegritySDLC GovernanceValidation Lifecycle ManagementElectronic Records/SignaturesAudit TrailsInspection ReadinessQuality Management SystemsCloud InfrastructureAutomation in Quality ProcessesRegulatory Submissions

Soft Skills

Analytical SkillsCommunication SkillsChange Management SkillsLeadership in Cross-Functional EnvironmentsCollaboration with Stakeholders

Tools & Technologies

Electronic Quality Management SystemsTraining SystemsRegulatory Data Management ToolsProject Management Tools

Certifications & Qualifications

ASQRACCSQESQESQAPMP

Industry Keywords

Medical DevicesPharmaceuticalBiotechRegulated IndustriesQuality StandardsGlobal Regulatory RequirementsDigital Transformation

Tech Stack

Tools & technologies

CloudPMPSDLC

About the role

Key responsibilities & impact

Provide strategic leadership for Medical Device Regulatory activities
Ensure integrity, governance, and effective use of regulatory data across the product lifecycle
Ensure J&J quality standards and global regulatory requirements are met
Embed quality early in design and development activities
Build controls within applications and solutions and use automation where feasible
Provide Technical Quality & Compliance expertise and guidance to project teams
Drive implementation and maintenance of systems delivered on time, within budget, and with high quality
Provide end-to-end Technology Quality leadership for projects and base business support teams across applications and cloud infrastructure
Lead the quality approach for systems and hold teams accountable for end-to-end support models
Partner with Regional Leads in support of the TQ&C Operating Model
Lead global teams with unique skills in cross-functional environments
Foster an environment aligned with the company credo and a diverse workforce
Serve as a trusted partner across the Technology Quality & Compliance organization and collaborate with senior internal and external stakeholders
Support regulatory submissions, compliance, digital transformation, and global regulatory readiness for DePuy Synthes

Requirements

What you’ll need

10-12 years of experience leading GxP computerized systems validation (CSV) within pharmaceutical, medical device, biotech, or other regulated industries
Deep understanding of GxP regulations and compliance requirements, including data integrity, SDLC governance, validation lifecycle management, electronic records/signatures, audit trails, and inspection readiness
Thorough knowledge of global cGMP regulations and computerized systems requirements
Bachelor’s degree in Computer Science, Information Systems, Business Administration, or another related field required
English required
Experience in medical devices, healthcare, or other highly regulated industries preferred
Experience working in global, matrixed organizations preferred
Familiarity with electronic quality management and training systems preferred
Demonstrated success driving quality system transformation or harmonization initiatives preferred
Quality or Regulatory certifications such as ASQ or RAC preferred
Excellent analytical, communication, and change-management skills preferred
Additional European languages preferred
Quality or Regulatory certifications, including CSQE, SQE, SQA, PMP, or similar, preferred but not required

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 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
Moderate international travel
Inclusive interview process and disability accommodations