Manager, Clinical QA Program Lead

Johnson & Johnson

Manager for Clinical QA programs at Johnson & Johnson focusing on audit strategies and GCP compliance. Leading audit initiatives and ensuring quality adherence across therapeutic areas.

Posted 7/17/2026full-timeSpring House • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $102,000 - $177,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expert-level knowledge in Good Clinical Practice (GCP) and compliance, with a strong ability to develop and implement audit strategies and conduct GCP audits. Leverages data analytics to identify trends and enhance audit quality across therapeutic areas.

Highest-signal resume keywords

GCP Audit ExperienceAudit Strategy DevelopmentData Analytics ProficiencyCompliance ExpertiseGxP Regulatory Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP AuditsAudit Strategy DevelopmentData AnalysisQuality Assurance AuditsRegulatory Compliance

Soft Skills

CollaborationCommunicationLeadership

Tools & Technologies

Data Analytics Tools

Industry Keywords

GxPClinical AuditTherapeutic AreasHealth Authority ComplianceAudit Report Peer Review

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits, ensuring connectivity and holistic alignment of strategies.
Fosters the partnership between audit strategy and execution teams and enhance the value of Clinical audit programs through enhancing the audit report peer review process and the analysis and communications of meaningful audit outcomes.
Monitors audit outcome trends and identification of pro-active collaboration opportunities with stakeholders to resolve and address compliance related matters and identify opportunities to enhance audit strategy and overall quality and compliance of clinical programs across therapeutic areas.
Maintains and shares expert-level GCP knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
Leverages data analytics tools to analyze relevant data sources.
Evaluates and analyzes the data to identify any relevant trends and insights as an input for the development of the appropriate audit program.
Conducts GCP audits & supports GxP Audits as applicable (expected up to 50% time) with a focus on audits relevant to the responsible therapeutic areas.
Develops tactical and operational audit plans to implement and deliver domain-specific audit strategies.
Ensures the relevant standard procedures, audit scopes and audit plans are fully understood and applied in audit activities.
Independently leads and manages the domain-specific compliance audit programs as laid down in a comprehensive audit schedule, through planning, conducting and reporting of QA audits of activities, data, internal and external facilities and processes in GxP/non-regulated areas to assure adherence to company internal standards and policies/requirements, and compliance with applicable (Health Authority) regulatory requirements.
Guides auditors in the scope definition, planning, conduct and reporting of audits, providing regulatory and process expertise within the applicable therapeutic area program(s).

Requirements

What you’ll need

Requires at least 5 years’ experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP-regulated discipline).
Experienced in conducting GCP audits.
Experienced in developing audit strategies and capabilities for applicable therapeutic program level(s), GCP System, and/or GCP Supplier audits.
Must be able to work onsite 3 days/week at JNJ location.

Benefits

Comp & perks

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