Clinical Quality Compliance Lead

Contract Length : 1 Year

Location : Hybrid - Cambridge, MA (2 days/week onsite)

Compensation : $100-115/hr

Job Summary

We are seeking an experienced Clinical Quality Compliance Lead to lead the development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA, and MPG studies. This role will act as the primary point of contact for key GCP strategic partners and will manage supplier quality partnership governance councils and internal supplier-related committees.

The ideal candidate will ensure the quality systems supporting clinical trial delivery are robust and aligned with regulations, including GCP policies. You will also be responsible for implementing quality risk management, conducting investigations, and leading corrective and preventive actions (CAPAs). This role is critical in ensuring compliance with applicable regulations and driving continual improvements.

Key Responsibilities

• GCP Supplier Audits & Compliance : Lead the development of risk-based GCP supplier audit strategies, manage supplier audits, and assess impact on subject safety and data integrity. Ensure audit reports and corrective actions are completed on time.
• Supplier Quality Oversight : Liaise with internal and external partners to provide compliance support, track supplier performance, and report metrics to management.
• GCP Oversight & Risk Management : Lead GCP oversight initiatives, including risk management and quality investigations. Develop CAPAs and track their effectiveness.
• Process Improvement : Lead process improvements and contribute to continual quality system enhancements.
• Inspection Readiness : Lead the clinical trial delivery system inspection readiness program, ensuring the organization is prepared for GCP inspections and responding to findings with effective CAPAs.
• Regulatory Expertise : Act as a subject matter expert in GCP and provide strategic input on regulatory inspections, including leading inspection response activities.

Education & Qualifications

Required :

• BA/BS degree; Advanced degree preferred
• Minimum of 10 years of experience in the pharmaceutical or biotechnology industry
• At least 7 years of GCP-related Quality Assurance experience
• Extensive knowledge of ICH GCP and global clinical development regulations
• Strong technical writing skills and ability to produce quality reports and documents

Preferred :

• GCP Quality Assurance certification
• Experience leading regulatory inspections and remediation activities
• Ability to manage global, cross-functional projects
• Fluency in English (additional languages a plus)

Travel Requirements

Approximately 30% travel, including international travel as needed.

How to Apply

Interested candidates are encouraged to apply with an updated resume highlighting relevant experience in GCP compliance and supplier quality management.