Senior Manager, Quality Systems

We are hiring a Senior Manager, Quality Systems. Reporting to the Director of Quality Assurance, this position will contribute to the implementation and management of Metagenomi’s quality systems and will manage QA Document, Training and Record management programs.  This role will be based in Emeryville, California. How you’ll contribute:  Lead QA function to ensure compliance of the overall Quality Management System and drive continuous improvement.  Implement and sustain the Quality Management system – eQMS in line with the required regulatory and industry standards. Lead the eQMS implementation project and perform routine department activities – Document Control, Record and Training Management. Serve as System Administrator for the eQMS – Experienced in Sparta (TrackWise) is a plus. Lead and manage training management programs. Implement and maintain programs and processes to ensure compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) Author, review and revise Standard Operating Procedures (SOPs) as needed to support the cGMP Technical Operation and regulatory requirements. Lead the Quality System Management functions to ensure alignment with manufacturing and servicing operations, support the lean efforts and drive quality improvement for products and services.  Provide quality viewpoints, opinions on future product and service development. Establish and publish the QMS KPIs report for department managers and management review meetings. Support internal/external and regulatory inspections. Serve as the Quality representative in cross-functional areas to support QA Doc. Control and Training management. Establish the work priorities to meet targets and timelines and effectively manage completing priorities with minimal supervision.  Participate in site quality improvement projects in the role of contributor, coordinator, or lead.  Provide team coaching and mentorship   Must haves:    Undergraduate degree in the life sciences or engineering and at least eight years of Biotech industry experience implementing and maintaining electronic quality management systems Leadership experience in industry QA Document Control, Record Management and Training Management processes Excellent analytical and problem-solving skills with keen attention to detail Strong knowledge of FDA guidelines and regulations regarding cGMPs, and advanced proficiency in eQMS, Microsoft office, Google Docs Strong interpersonal, written, and oral communication skills A solution and team-oriented mindset, the ability to manage multiple priorities simultaneously, and a drive to make an impact. California Pay Transparency Disclosure: This position is classified as an exempt salaried position under the Federal Labor Standards Act.  The anticipated base salary range for this position will be $175,000 to $185,000.  You will also be eligible to receive equity, bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.  #LI-NG1   About Metagenomi Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world. For more information, please visit https://metagenomi.co/.   What makes Metagenomi a unique place to work? We are passionate about developing technologies derived from microbial-rich ecosystems that have the power to enable therapeutic development and the potential to cure devastating disease. We have cultivated an amazing culture that values teamwork, curiosity, scientific rigor, and fun. We have a strong commitment to work/life balance, host a weekly employee happy hour and events, provide catered lunches and endless snacks, and more!  We offer competitive compensation including a market-benchmarked salary, annual target bonus, equity in an early-stage startup, and a comprehensive benefits plan, including 401(k) matching, a retirement safe harbor plan, and other perks.   At Metagenomi, we know that our people drive our success. We are an equal-opportunity employer and believe in and value diversity and inclusion. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. Metagenomi does not discriminate on the basis of race, color, religion, sexual orientation, gender, age, physical or mental disability, or any other status protected under federal, state, or local law. Please note, all candidates must be authorized to work in the United States.   Applicants/Employees have rights under various State and Federal Employment Laws, including without limitation:   Family & Medical Leave Act    Equal Employment Opportunity Commission   Employee Polygraph Protection Act    California Family Rights Act    California Fair Employment and Housing Act   Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Metagenomi. Agencies and independent recruiters must be approved as a vendor by Metagenomi’s Talent Acquisition team. To protect the interests of all parties, Metagenomi will not accept unsolicited resumes, profiles, or biographies. Any unsolicited resumes sent to Metagenomi will be considered referrals and the property of Metagenomi.