Principal Clinical QA Auditor

Principal GCP Quality Auditor

Location: Hybrid in MA

A leading global healthcare organization is seeking a seasoned professional to join its Clinical Quality Assurance team. This role will be responsible for conducting comprehensive audits of clinical processes and external service providers to ensure compliance with international regulations and internal standards. The position spans multiple clinical divisions and involves close collaboration with cross-functional teams including sourcing, partnerships, supplier quality, and software quality.

Key Responsibilities

• Lead and execute global audits of clinical processes and vendors.
• Conduct risk-based assessments of specific clinical activities.
• Collaborate with subject matter experts to evaluate vendor services, including digital and software components.
• Prepare detailed audit reports and communicate findings to stakeholders.
• Manage and resolve non-conformances related to clinical vendors.
• Stay current with and apply relevant regulatory frameworks (e.g., ISO standards, FDA regulations, GCP).
• Partner with internal teams to oversee vendor performance and compliance.
• Support regulatory inspections and readiness activities.
• Contribute to quality improvement initiatives within the Clinical QA community.

Qualifications

Required:

• Bachelor's degree in a scientific or health-related discipline.
• At least 10 years of experience in a regulated industry (e.g., medical devices, pharmaceuticals).
• Proven auditing experience in GCP-regulated environments.
• Certified Lead Auditor in ISO 13485.
• Strong ethical standards and professional credibility.
• Willingness to travel internationally.

Preferred:

• Familiarity with global regulatory requirements and standards.
• Knowledge of ISO 14155, GCP, real-world data vendors, and digital health technologies.
• Additional certifications (e.g., ASQ, SOCRA, RQAP-GCP).
• Experience working across diverse teams and functions.