Manager, Clinical QA Program Lead

Johnson & Johnson

Manager overseeing Clinical QA Program while implementing audit strategies in a global healthcare company. Collaborating across multiple locations and ensuring compliance with regulatory requirements.

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 of Good Clinical Practice (GCP) and GxP regulations, with a strong focus on developing and executing audit strategies for clinical programs. Proven ability to analyze audit outcomes and collaborate with stakeholders to enhance compliance and quality across therapeutic areas.

Highest-signal resume keywords

GCP Audit ExperienceAudit Strategy DevelopmentCompliance MonitoringStakeholder CollaborationGxP Audit Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP KnowledgeAudit Strategy DevelopmentCompliance AnalysisAudit Outcome MonitoringGxP Regulations

Soft Skills

CommunicationCollaborationCritical Thinking

Industry Keywords

Clinical AuditTherapeutic AreasQuality ComplianceClinical SystemsClinical Suppliers

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Drive and deliver audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits.
Foster 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.
Monitor 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.
Maintain and share expert-level GCP knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
Conduct GCP audits & support GxP Audits as applicable (expected up to 50% time) with a focus on audits relevant to the responsible therapeutic areas.

Requirements

What you’ll need

A minimum of a bachelor’s or equivalent University degree is required.
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

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