Advanced Clinical

Compensation

Full Description

Quality Assurance Senior Specialist, R&D Position Summary Seeking a Quality Assurance Senior Specialist, R&D to provide quality oversight and support for clinical research programs. In this role, you will partner closely with cross-functional R&D teams to ensure the highest standards of regulatory compliance and data integrity in the execution of clinical trials. You will serve as a Quality Assurance subject matter expert (SME) and key liaison with external partners—including CROs, laboratories, and other vendors—to ensure systems, processes, and deliverables meet global regulatory expectations and quality standards. Key Responsibilities • Review clinical study documents to ensure consistency, accuracy, and compliance with company procedures, regulations, and best practices. • Serve as a quality SME, guiding R&D personnel in investigations, root cause analyses, and CAPA activities. • Act as Quality approver for deviations and CAPAs related to assigned studies. • Participate as a GCP expert in cross-functional teams, providing risk-based compliance guidance. • Serve as the Quality contact for audits of vendors, investigator sites, and study-specific audits (e.g., CSR and TMF). • Identify, recommend, and implement quality process and system improvements. • Assess and communicate compliance risks, supporting development of mitigation and resolution plans. • Support and lead inspection readiness (IR) activities for assigned studies; actively participate in regulatory inspections. • Coordinate and manage projects to ensure timely completion of quality deliverables. • Perform other related duties as assigned. Qualifications Education: • Bachelor’s degree (BA/BS) required, preferably in a Life Science discipline. Experience & Competencies • Minimum 5 years of GCP Quality Assurance experience in a regulated industry (pharma, biotech, CRO, or medical device). • In-depth knowledge of FDA and ICH Good Clinical Practice (GCP) regulations and requirements. • Proven experience supporting Regulatory Authority GCP inspections. • Skilled in managing internal stakeholders, external vendors, and auditors. • Strong communication and collaboration skills, with a non-confrontational and solutions-oriented approach. • Demonstrated ability to thrive in a fast-paced, dynamic environment with multiple priorities and evolving demands.