Director/Sr. Director, Quality OperationsAlameda, CA
Scribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by Design platform for CRISPR-based genetic medicine.
We are seeking a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. The current role is for a Director / Senior Director, Quality Operations to join our team and advance our platform. The candidate should have a passion for working collaboratively with nonclinical, clinical and CMC team members to enable building Quality Operations and Compliance strategies for CRISPR-based therapeutics. Furthermore, the candidate would offer expertise in efficiently navigating the GXP complexities inherent to gene editing programs.
Key Responsibilities: Lead our growing quality functionsBuild and lead a strong QMS, ensuring compliance with regulatory requirements, maintaining audit readiness and interfacing with CDMO/CRO quality and technical teams, and driving continuous improvement initiatives across all aspects of our operationsDevelop and implement quality management systems (QMS) in accordance with applicable regulations (e.g., FDA, EMA, ICH) and industry best practicesOversee all quality control and quality assurance activities throughout the product or project lifecycle, including supplier qualification and raw material testing, in-process monitoring, and final product releaseCollaborate with stakeholders on quality and compliance aspects of technology transfer and new product introductionServe as an expert resource for GXP training activitiesEstablish and maintain key performance indicators (KPIs) to track and improve quality metrics for management reviewDevelop and maintain process(es) for product life cycle management from Research to Development and into ClinicStay abreast of emerging regulations, guidance, standards, and industry trends relevant to cell and gene therapy productsConduct internal audits and provide support towards interactions with Regulatory agencies, ensuring adherence to GXPCollaborate with cross-functional teams to address compliance issues, CAPAs, and quality system deficienciesChampion a culture of compliance and quality excellence through training, coaching, and fostering a mindset of continuous improvementLead risk assessment activities to identify and mitigate quality and regulatory risksDevelop risk management plans and ensure proactive risk mitigation strategies are implementedRecruit, mentor, and develop a high-performing team of quality professionalsProvide strategic direction and leadership to the quality teamAssist in developing and supporting an operating budgetCollaborate cross-functionally on regulatory submissionsProvide Quality review and impact assessment of proposed Change Control recordsRequired Skills and Background: Minimum 10 years experience in quality assurance, quality control, and/or quality operations within the biotechnology industryIn-depth knowledge of global regulations governing cell and gene therapy productsStrategic thinker with a demonstrated ability to develop and implement quality and regulatory strategiesAttention to detail and ability to lay out Quality Operations into systems processes and proceduresExperience writing SOPs, reviewing protocols and reports, and maintaining a document control systemExperience with QMS and ability to onboard, implement and maintain a validated QMSExceptional communication skills to mentor and train in compliance mattersExperience with regulatory inspections and/or CDMO/CRO auditsStrong collaboration skills with a congenial attitudeAbility to manage complex schedules and shifting priorities in a dynamic environmentSalary will be commensurate with experience. We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to engineer the future of therapeutics, then we are excited to hear from you!
We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.
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