Global Quality Assurance Auditor

GE HealthCare

. Support a program (plan, prepare and execute) of internal and external audits for QRA .

Posted 4/24/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $106,400 - $159,600 per yearWebsite

About the role

Key responsibilities & impact

Support a program (plan, prepare and execute) of internal and external audits for QRA
Ensure all identified actions / observations are appropriate to remediate the deficiency and are completed in a timely manner and complete reviews to ensure effectivity
Work with the customer to undertake risk analysis of systems and processes, to propose process / functional audits
Support regulatory inspections and customer audits as a functional QA subject matter expert
Conduct trend analysis of audit and other quality related data, provide to internal / external stakeholders as agreed
Assure completion of vendor qualification and surveillance activities performed and documented as defined in global and functional procedures
Participates in the quality management system (QMS) improvements
Provide guidance and ensure that ‘CAPA’s are correctly set up to capture risk assessment, effective corrective and preventive actions and have the required evidence
Perform QA approvals of Quality Event records
Keep up to date with latest guidelines from MHRA, FDA, EMEA and other Regulatory bodies
Monitor legislation, implementing changes, and informing the company of any relevant changes.
Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned

Requirements

What you’ll need

Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 8 years of experience in pharmaceutical industry)
6+ years of experience in the pharmaceutical industry
Previous Auditing experience required
Experience interfacing with global regulatory agencies
Ability to comprehend and communicate key regulatory requirements and expectations
Experience in collaboration, negotiation & conflict resolution skills
Knowledge of GPvP, cGMP, and GDP

Benefits

Comp & perks

medical
dental
vision
paid time off
a 401(k) plan with employee and company contribution opportunities
life
disability
accident insurance
tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

auditingrisk analysistrend analysisvendor qualificationCAPAquality management systemQA approvalsquality event recordsregulatory compliancedata analysis

Soft Skills

collaborationnegotiationconflict resolutioncommunicationguidancemanagementtimelinesseffectivitystakeholder engagementproblem-solving

Certifications

Bachelor's degreeGED