Hiring: Associate Director, Quality Assurance (GCP & Clinical Research) Company: IQVIA Location: Durham, NC Job Posted Time: 2026-09-15 15:01:06 Target Skills & Keywords : GCP, Microsoft Office, Quality Assurance, Regulatory Compliance, Risk Management About the job Experience: •10 years of Quality Assurance experience within pharmaceutical, biotechnology, CRO, medical device, healthcare, or clinical research environments. Required Skills: •Serve as the primary QA liaison for assigned customers, sponsors, clinical operations groups, and internal functional areas. •Provide Quality Assurance oversight and guidance of quality issues, deviations, CAPAs, risk assessments, and compliance initiatives. •Serve as a subject matter expert in GCP, GxP, ICH guidelines, clinical trial regulations, and pharmaceutical quality requirements. •Provide guidance, interpretation, training, and consultation regarding regulations, industry standards, corporate policies, and quality expectations to clinical and operational teams. •Support inspection readiness activities and support responses to regulatory authority inspections, sponsor audits, and customer audits. •Assist in the enhancement of Quality Assurance policies, procedures, and risk management programs by providing recommendations to regional and global QA leadership. •Author, review, and maintain Quality Assurance Standard Operating Procedures (SOPs) and serve as a representative on global quality governance initiatives, if assigned. •Support customer audits and regulatory inspections and support the development, implementation, and verification of corrective and preventive action (CAPA) plans. Qualifications: •Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology, Chemistry, or related scientific discipline, or equivalent combination of education and experience preferred •Minimum of 10 years of Quality Assurance experience within pharmaceutical, biotechnology, CRO, medical device, healthcare, or clinical research environments. •Extensive experience interpreting, applying, and overseeing compliance with Good Clinical Practice (GCP) standards within a clinical research environment. •Strong knowledge of pharmaceutical research and development processes, clinical trial conduct, and global regulatory environments. •Demonstrated experience in GxP Quality Assurance, Experience conducting audits, authoring audit reports, evaluating findings, and managing CAPA activities is an advantage. •Proven ability to lead complex quality initiatives and influence stakeholders across multiple functions and organizational levels. •Excellent problem-solving, risk assessment, negotiation, and decision-making skills. •Strong organizational, communication, leadership, and team-building abilities. •Demonstrated capacity to establish and maintain effective working relationships with customers, regulators, vendors, and internal stakeholders. •Proficiency with Microsoft Office applications and quality management systems. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!