Clinical Quality Compliance Lead

Clinical Quality Compliance LeadContract Length1 YearLocationHybrid - Cambridge, MA (2 days/week onsite)Compensation$100-115/hrJob SummaryWe 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 ResponsibilitiesGCP Supplier Audits & ComplianceLead 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 OversightLiaise with internal and external partners to provide compliance support, track supplier performance, and report metrics to management.GCP Oversight & Risk ManagementLead GCP oversight initiatives, including risk management and quality investigations. Develop CAPAs and track their effectiveness.Process ImprovementLead process improvements and contribute to continual quality system enhancements.Inspection ReadinessLead the clinical trial delivery system inspection readiness program, ensuring the organization is prepared for GCP inspections and responding to findings with effective CAPAs.Regulatory ExpertiseAct as a subject matter expert in GCP and provide strategic input on regulatory inspections, including leading inspection response activities.Education & QualificationsRequiredBA/BS degree; Advanced degree preferredMinimum of 10 years of experience in the pharmaceutical or biotechnology industryAt least 7 years of GCP-related Quality Assurance experienceExtensive knowledge of ICH GCP and global clinical development regulationsStrong technical writing skills and ability to produce quality reports and documentsPreferredGCP Quality Assurance certificationExperience leading regulatory inspections and remediation activitiesAbility to manage global, cross-functional projectsFluency in English (additional languages a plus)Travel RequirementsApproximately 30% travel, including international travel as needed.How to ApplyInterested candidates are encouraged to apply with an updated resume highlighting relevant experience in GCP compliance and supplier quality management.

Created: 2025-01-19