Job Description:

Title: Associate Director/ Director of Quality AssuranceCheck out the role overview below If you are confident you have got the right skills and experience, apply today.Status: 12 month contractHours: 20-30 per weekLocation: Onsite in South San FranciscoHourly rate: $100-$130 per hour depending on experienceThis is a hands-on position responsible for all assigned activities that ensure manufacturing activities adhere to applicable GMP regulations.Other duties:Support managing a risk-based Quality Management System (QMS) for GMP/GLP QA in compliance with applicable regulatory requirements (United States and other global countries), and company policies.Author and review novel, compliant processes with associated Standard Operating Procedures through gap analysis.Continue to foster companies culture of continuous improvement with emphasis on efficiency and effectiveness.Achieve assigned deliverables of the GMP/GLP QA function.Required Skillsets:BS/BA degree required, advanced degree in a scientific field preferred. Quality assurance professional certification and/or certified quality auditor is a plus.At least 10+ years of experience pharmaceutical or biotechnology industry cGMP experience with 4+ years of relevant experience in GMP Quality Assurance.Extensive experience reviewing batch records for contract manufacturing organizations, contract testing laboratories, and suppliers for drug substance (DS), drug product (DP) and packaging. This includes managing and performing supplier audits, developing audit agendas, writing audit reports, approving audit responses, developing/reviewing supplier quality agreements, performing batch record review/approval to support DS and DP disposition activities.Strong hands-on experience with developing, implementing, maintaining, and improving Quality System processes and procedures to ensure the system adheres to regulatory and requirements.In-depth knowledge of ICH, FDA, and EU GMP and GLP regulations with all phases of drug development.All onsite employees and contractors to be fully vaccinated prior to their first day.