BioSpace is hiring: Director - Quality Assurance & Automation (REMOTE in Redwood

57 - Quality Assurance Full Time Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a Director of Quality Assurance. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. Codexis enzymes solve for real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesis™ platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. Codexis enzymes can drive improvements, such as higher yields, reduced energy usage and waste generation, improve efficiency in manufacturing and greater sensitivity in genomic and diagnostic applications. We empower employees to be authentic, ambitious, agile and have the courage to take action where they can make a positive impact. Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health. About the Opportunity: The Director of Quality Assurance is responsible for quality functions including disposition of enzymes, deviation resolution, CAPAs, change control, lab investigations, documentation supporting the suitability of the batches, completion of customer questionnaires, development/creation of quality systems and internal audits. Ability to manage QA staff and projects (direct and indirect) and variable workloads to timelines. Product disposition and QA support for the manufacture and testing of Codexis products. Work directly with internal operational groups to ensure that products meet all required quality standards, specifications and requirements. Provide QA leadership and collaborate with Supply Chain, Manufacturing, Quality Control, Analytical Development and Regulatory to ensure that internal operations achieve and maintain compliance with Codexis quality standards. Develop, establish, and maintain internal quality systems and processes. Write, review, and approve SOPs and various other documents for consistency with quality principles and existing quality systems. Coordinate and facilitate with CMOs to achieve quality objectives and resolution of quality issues. Lead internal audit program and prepare for and host customer quality audits. BA or BS degree in a scientific discipline; A minimum of 15 years of experience in Quality Assurance Management supporting manufacturing and quality control in a pharmaceutical or biotech environment. In-depth knowledge and application of GMP and ICH Guidelines. Technical experience or understanding in fermentation/DSP and quality control. Previous responsibility for assessing whether products meet specifications, required quality standards and determining disposition of products. Previous experience building efficient quality systems. Medical, Dental and Vision Insurance ~ Basic Life, AD&D, Short- and Long-Term Disability Insurance ~Company Equity ~ Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time ~ Annual Lifestyle Account for reimbursement of fitness programs, equipment and more ~ Employee Stock Purchase Program (ESPP) ~ Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare) ~ Onsite Gym Facilities ~ We foster career growth, continued education and upskilling through our mentorship program and learning and development opportunities. You will learn and work alongside inspirational leaders and colleagues who are equally passionate about our mission and committed to fostering an inclusive, growth-centered, and rewarding culture. Diversity is valued and mutual trust is of paramount importance to the ethos at Codexis. Codexis is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. Codexis is a leading enzyme engineering company leveraging our proprietary CodeEvolver® technology platform to discover and develop novel, high performance enzymes for three healthcare industry pillars: pharmaceutical manufacturing, life sciences, and biotherapeutic discovery & development. The enzymes we produce aim to solve real-world challenges associated with small molecule pharmaceuticals manufacturing, nucleic acid synthesis and genomic sequencing, and - as biotherapeutic candidates - they have the potential to treat challenging diseases. We empower employees to be authentic, ambitious, agile and have the courage to take action where they can make a positive impact. Whether you are driven by science, or a different area of expertise, we need you to help us create a brighter future. Website Phone 650-421-8100 Location 200 Penobscot Drive Facebook Twitter LinkedIn