Senior Director Quality Assurance
StaffWorks, LLC - san diego, CA
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We are seeking an experienced Director or Senior Director of Quality Assurance to lead the quality assurance function, ensuring rigorous quality standards throughout our drug discovery and development process. This role will establish, implement, and manage quality systems, ensuring compliance with GxP (GMP, GLP, GCP) standards across internal operations and external partners (CDMOs, CROs). Reporting to senior leadership, the DirectorSenior Director will foster a quality-focused culture, implement proactive risk management, and lead continuous improvement initiatives to maintain excellence across our pipeline.Key Responsibilities:Quality Strategy & Leadership:Develop and implement a strategic Quality Assurance plan that aligns with corporate goals and regulatory standards.Lead the design and deployment of a robust Quality Management System (QMS), ensuring compliance with FDA, EMA, and other regulatory requirements.Champion a quality culture across the organization, promoting proactive quality practices and continuous improvement.Quality Systems Management:Oversee the creation, maintenance, and improvement of quality systems, including SOPs, change control, CAPA management, documentation, and training programs.Ensure that all internal and CDMOCRO operations meet GxP standards, supporting seamless inspection readiness.Collaborate with cross-functional teams to establish quality metrics, KPIs, and dashboards to monitor and report on QMS pliance and Inspection Readiness:Manage internal and external audits, inspections, and vendor qualifications, addressing any compliance issues promptly.Oversee the preparation, review, and approval of GMP documentation, including batch records, validation reports, and clinical trial material (CTM) labeling, packaging, and distribution.Partner with Regulatory Affairs to ensure successful regulatory submissions, inspections, and audits.Risk Management & Continuous Improvement:Lead proactive risk assessments and implement corrective and preventive actions (CAPAs) to address potential quality risks.Drive continuous improvement initiatives that enhance product quality, operational efficiency, and regulatory compliance.Requirements:Bachelor's degree in Chemistry, Biology, or related life sciences field; advanced degree preferred.Minimum of 10-15 years of experience in Quality Assurance, with a focus on cGMP manufacturingExtensive knowledge of global GxP regulations, QMS best practices, and quality systems for small molecule drug development.Proven success in leading regulatory inspections and audits (FDA, EMA).Strong organizational, analytical, and problem-solving skills, with a meticulous attention to detail.Excellent interpersonal and communication skills, with the ability to work effectively across internal teams and with external partners (CDMOs, CROs, vendors).
Created: 2024-10-20