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Associate Director, Standard Operating Procedure Author Associate Director of Process Development and Documentation Meet Life Sciences San Francisco Bay Area (Hybrid) Associate Director of Process Development and Documentation | Clinical Quality Assurance (CQA) Professional Summary: A highly experienced Clinical Quality Assurance professional with over 10 years of expertise in developing and maintaining clinical research SOPs, process development, and compliance for clinical-stage pharmaceutical companies. Proven leader with strong technical writing skills, capable of working cross-functionally to ensure adherence to industry standards and regulatory requirements. Experienced in managing audits, inspections, and continuous improvement of the Quality Management System (CQMS). Key Skills & Expertise: Process Development & Documentation: Expertise in developing and maintaining GCP, GLP, and GVP processes and SOPs. Adept at mapping and documenting clinical processes for clinical trials. SOP Writing & Compliance: Strong experience in developing and reviewing SOPs, ensuring compliance with regulatory guidelines, and maintaining review timelines. Inspection & Audit Support: Expertise in preparing for regulatory inspections (e.g., FDA, EMA) and supporting GCP, GLP, and GMP inspections. Experience in qualification audits of clinical service providers, investigator sites, and internal audits. Non-Compliance & CAPA Management: Skilled in leading non-compliance event investigations and implementing corrective and preventive actions (CAPA). Focus on trends such as protocol deviations, safety, and other clinical data. Leadership & Mentorship: Proven ability to lead cross-functional teams, mentor junior staff, and promote talent development within the Clinical Quality Assurance team. Quality Metrics & Trend Analysis: Proficient in performing quality metric analysis to monitor clinical process deviations and CAPA effectiveness. Industry Knowledge & Regulatory Trends: In-depth understanding of regulatory changes and industry trends related to clinical development and GCP, GLP, GVP compliance. Professional Experience: Led the development and documentation of GCP, GLP, and GVP SOPs, ensuring alignment with regulatory requirements and best industry practices. Collaborated with Clinical Development teams to create and implement processes supporting clinical trials, focusing on quality assurance and compliance. Managed cross-functional teams responsible for the creation and review of clinical SOPs and guidance documents. Actively supported inspection readiness and prepared teams for regulatory inspections, ensuring compliance and mitigating risk. Conducted audits of clinical documentation and service providers, including TMF and CSR reviews, ensuring adherence to SOPs and regulatory guidelines. Led investigations into non-compliance events, developing and implementing CAPAs to address protocol deviations and safety issues. Spearheaded the continuous improvement of the Quality Management System (CQMS), overseeing the creation and revision of SOPs and training programs. Provided mentorship and development opportunities for junior team members, fostering a collaborative and growth-oriented environment. Supported the development and implementation of GCP, GLP, and GVP SOPs, collaborating with clinical teams to ensure compliance with industry standards. Led the preparation for regulatory inspections, ensuring clinical trial documentation met all regulatory agency requirements. Performed quality metric analysis, identifying trends and ensuring corrective actions were implemented to improve compliance and reduce non-compliance events. Assisted in the management and growth of the Clinical Quality Assurance team, contributing to team building, recruitment, and staff development. Education: Bachelor of Science (BS) in Biological Sciences (or related field) Technical Skills: Microsoft Office (Word, Excel, PowerPoint) : Advanced proficiency. Process Development Tools : Experienced in using industry-standard tools for process mapping and documentation.