Job Description

Sr. GCP Quality Specialist

Location: Hybrid in MA

We are seeking a Senior GCP Quality Specialist to play a critical role in maintaining the integrity and compliance of clinical research operations. In this global role, you will lead audits of clinical processes and vendors, ensuring they meet regulatory requirements and internal quality standards.

Responsibilities:

• Lead clinical audits: Conduct in-depth audits of clinical processes and vendors across multiple divisions to ensure compliance with global regulations and internal protocols.
• Risk-based quality assessments: Identify key risk areas in clinical operations and execute targeted audits to address compliance gaps.
• Vendor evaluations: Partner with subject matter experts (e.g., software quality) to perform comprehensive vendor assessments and ensure all provided services meet regulatory standards.
• Drive accountability: Prepare clear, actionable audit reports and communicate findings with stakeholders to facilitate timely resolution.
• Manage non-conformances: Oversee clinical vendor compliance issues, working cross-functionally to implement corrective actions.
• Stay ahead of regulations: Continuously monitor and interpret evolving regulatory guidelines, such as ISO standards, FDA medical device regulations, and Good Clinical Practice (GCP) requirements, to keep the organization compliant.
• Regulatory readiness: Support preparation and participation in regulatory inspections related to clinical operations.
• Quality improvement initiatives: Contribute to the Clinical Quality Assurance Community of Practice by identifying opportunities for process enhancements and best practices.

Qualifications:

• A Bachelor's degree in Science, Health, or a related field.
• At least 5 years of experience in a regulated industry such as medical devices, pharmaceuticals, or a similar field.
• Hands-on auditing experience in a GCP-regulated environment or equivalent.
• Willingness and ability to travel as needed for audits and inspections.
• Lead Auditor certification in is a plus
• Must be authorized to work in the US without Visa sponsorship

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