Director/Senior Director, Clinical Quality Assurance

May 9

Annexon Biosciences

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Unlocking the Next Generation of Complement Therapies

Neurodegeneration • Autoimmune • Ophthalmology

51 - 200

💰 $130M Post-IPO Equity on 2022-07

Description

• Lead the clinical Quality Assurance program • Develop quality systems for clinical trials adherence • Manage quality operations and audit processes • Implement and oversee Quality Assurance Systems compliance • Develop training programs and conduct audits • Collaborate with cross-functional teams and internal/external stakeholders • Lead additional Quality Assurance initiatives

Requirements

• Undergraduate or graduate degree in Pharmaceutical Sciences, Chemical Engineering, or related discipline • 10+ years of experience in clinical quality assurance in biotechnology/pharmaceutical industry • Strong knowledge of US Code of Federal Regulations, ICH Guidelines, and other local regulatory requirements • Expertise in creating and executing audit plans • Excellent communication and leadership skills • Detail-oriented, organized, and able to manage multiple projects

Benefits

• Diversity, Equity, Inclusion, and Belonging initiatives • Flexible work schedules and remote opportunities • Comprehensive health benefits package • Competitive base salary and equity participation