Global QA Auditor & Compliance Lead (Remote)

Merck; Rahway (NJ); A distancia; USD 129.000 - 203.000; Jornada completa

Descripción de la vacante

Merck in Rahway, NJ seeks an experienced QA Clinical Quality professional to provide independent assurance of safety, rights and well-being of trial participants, ensuring data integrity and regulatory compliance across global studies.

You will audit investigator sites and third parties, collaborate with teams in Asia and the US, travel frequently (75%), and drive CAPA remediation while aligning with QALs and senior leadership.

Formación

• Bachelor's degree (BS/BA) or equivalent preferred.
• Minimum of 5 years of experience in a relevant field.
• Experience in QA, GCP, regulatory compliance and audits.

Responsabilidades

• Prepare and conduct QA audits, generate reports and communicate results to QA stakeholders.
• Collaborate with teams across regions (incl. China/Japan) to understand regulatory requirements.
• Analyze critical quality factors to identify risks and perform risk-based audits.
• Perform GCP routine and directed audits of sites, suppliers and third parties.
• Support QALs in identifying audit substrates for China and scheduling.
• Travel up to 75% to Asia Pacific (China) and ROW as needed.

Conocimientos

Accountability

Ownership

Execution

Influencing

Networking

Coaching

Talent Growth

Audit Management

Quality Assurance

Regulatory Compliance

Risk Management

Corrective Actions

Educación

Bachelor's degree (BS/BA) or equivalent preferred

Descripción del empleo

Merck in Rahway, NJ seeks an experienced QA Clinical Quality professional to provide independent assurance of safety, rights and well-being of trial participants, ensuring data integrity and regulatory compliance across global studies.

You will audit investigator sites and third parties, collaborate with teams in Asia and the US, travel frequently (75%), and drive CAPA remediation while aligning with QALs and senior leadership.