Global PV QA Auditor - Impactful Compliance Leader

GE HealthCare (United States); United States; A distancia; USD 102.000 - 153.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Tuition reimbursement

Benefits package

Descripción de la vacante

GE HealthCare is seeking a QA Auditor for Pharmaceutical Diagnostics (PDx) focused on GMP manufacturing and Pharmacovigilance (PV) compliance. The role emphasizes audits, regulatory oversight, and continuous improvement across global sites.

The position requires experience in pharmaceutical auditing, regulatory interfaces, and CAPA management, with ongoing monitoring of MHRA, FDA, and EMEA guidelines. Collaboration with cross-functional teams is essential.

Formación

• Auditing experience in pharmaceutical industry and quality systems.
• Ability to interpret and apply regulatory expectations from MHRA, FDA, EMEA.
• Strong communication and collaboration skills across global stakeholders.

Responsabilidades

• Plan, prepare and execute internal and external audits for QRA.
• Ensure corrective actions are remediated in a timely manner and reviews completed for effectiveness.
• Analyze risks and propose process and functional audits with stakeholders.
• Support regulatory inspections and customer audits as QA SME.
• Conduct trend analyses of audit data and share insights with stakeholders.
• Oversee vendor qualification and surveillance per global procedures.
• Contribute to QMS improvements and CAPA management.
• Stay updated on evolving regulations and assess impact on procedures.

Conocimientos

Auditing experience

Regulatory knowledge

Communication skills

Educación

Bachelor's degree in related field

High school diploma with 8+ years pharmaceutical experience

Descripción del empleo

GE HealthCare is seeking a QA Auditor for Pharmaceutical Diagnostics (PDx) focused on GMP manufacturing and Pharmacovigilance (PV) compliance. The role emphasizes audits, regulatory oversight, and continuous improvement across global sites.

The position requires experience in pharmaceutical auditing, regulatory interfaces, and CAPA management, with ongoing monitoring of MHRA, FDA, and EMEA guidelines. Collaboration with cross-functional teams is essential.