Overview
Clinical Quality Assurance Jobs in Cambridge, MA at Integrated Resources, Inc ( IRI )
Title: Clinical Quality Assurance
Company: Integrated Resources, Inc ( IRI )
Location: Cambridge, MA
Position Summary:
The Sr. Manager, R&D Quality Assurance will serve as the QA Program Lead (PL), providing independent Clinical Quality Assurance oversight for assigned clinical studies. This role ensures compliance with protocols, international/local regulations, GCP, and internal SOPs. The Sr. Manager will lead inspection readiness activities and audit functions for Phase 2 and 3 trials, supporting high-quality, compliant clinical trial execution.
Key Responsibilities:
Independently perform the QA Program Lead (PL) role per Program Lead Plan, overseeing protocol, SOP, GCP, and regulatory compliance.
Lead and execute study audit plans, including Investigator Site Audits (ISA) selection, report generation, CAPA development, and co-/lead audits as required.
Direct inspection readiness for assigned studies, managing IR workstreams across all functional areas, and guide preparation for global health authority inspections (FDA, EMA, PMDA, etc.).
Manage quality events (non-compliance, investigations, root cause analysis, impact assessment, CAPA) for sponsor, site, and vendor issues.
Provide guidance to junior QA staff, ensure cross-functional collaboration, and contribute to process improvement, regulatory intelligence, and SOP/tool updates.
Qualifications:
Bachelor’s degree (life sciences, pharmacy, technology, or health-related discipline required); Master’s degree preferred.
Minimum 7 years’ GCP Quality Assurance or equivalent clinical trial experience.
Experience overseeing late-phase clinical trials and leading audits.
Proven ability in inspection readiness activities and direct regulatory inspection management.
Strong knowledge of GCP, ICH, FDA, EMA, and other regulatory requirements; experience collaborating across Clinical Operations, Regulatory Affairs, Drug Safety, Data Management, etc.
Additional Information:
Travel: 10–25% (domestic/international)
Reports to: Director, GCP QA (or designee)
Other duties as assigned by QA management
