Qualifications:Bachelor’s degree in scientific, legal, or other applicable discipline, with 10+ years in the pharmaceutical industry, with exposure to multiple regulated areas, or equivalent experienceDirect experience auditing and overseeing GCP complianceExperience in GLP and/or GVP quality is strongly desired Knowledge of GCP compliance activities necessary for clinical trial management and study site managementDemonstrated experience in leading, managing and improving pharmaceutical quality systemsExperience with RBQM and Quality by designExperience working with and overseeing external service providersHands-on experience participating in regulatory inspectionsDemonstrated experience in managing pharmaceutical quality systems such as Management Review, Document Management, Training, Deviation/Investigation, CAPA, and Quality Metrics reportingGeneral understanding of pharmaceutical research and development; ability to partner with the business functions to enable high quality outcomesExperience using Veeva Quality Management systems is strongly desiredStrong leadership, technical, management, problem solving and project management skillsGood presentation, verbal and written communication skillsThe anticipated annualized base pay range for this full-time position is $205,000-$250,000. Position Summary:The Director, R&D Quality Management provides leadership for the company’s GCP, GLP, and GVP audit and vendor management programs, ensuring a risk-based approach that strengthens oversight and anticipates emerging quality risks.