Global Quality Assurance Auditor, Pharmacovigilance

GE HealthCare

Quality Assurance Auditor providing QA auditing for Pharmaceutical Diagnostics business at GE HealthCare. Responsible for regulatory compliance, auditing, and quality management system improvements.

Posted 6/18/2026full-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

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

auditingrisk analysistrend analysisvendor qualificationCAPAQA approvalsquality management system (QMS)quality event records

Soft Skills

collaborationnegotiationconflict resolutioncommunication

Certifications

Bachelor's degreehigh school diplomaGED