Latigo Biotherapeutics, Inc.
Associate Director, Quality Assurance
Latigo Biotherapeutics, Inc., Thousand Oaks, California, United States, 91362
Location: Thousand Oaks or San Francisco (on-site)
Latigo is seeking an experienced Associate Director, Quality Assurance to facilitate development of the leading, clinical-stage pipeline of non-opioid pain medicines. This individual will serve as the internal Quality lead, providing strategic oversight of GxP compliance, quality systems, and vendor management. This role will leverage external consultants for specialized technical QA functions while ensuring Latigo maintains a robust, phase-appropriate quality culture.
About You
Fast-acting, relentlessly agile, and mission-oriented Bachelor’s degree in life sciences or related field. Advanced degree preferred. 7+ years of experience in Quality Assurance within the biopharmaceutical industry, with a focus on clinical-stage development. In-depth knowledge of GxP regulations (FDA, EMA, ICH). Experience in both GCP and GMP Quality preferred. Strong track record managing QA systems, vendor oversight, and regulatory inspections. Ability to work independently in a lean environment, balancing strategic oversight with hands-on execution. Strong communication, leadership, and organizational skills with the ability to influence cross-functional stakeholders. Key Responsibilities
Quality Leadership & Oversight: Develop, maintain, and continuously improve the company’s Quality Management System (QMS) in alignment with clinical-stage regulatory expectations. Partner with the Program Teams to integrate Quality into overall development strategy and decision-making. Act as the primary point of contact for internal QA matters and regulatory inspection readiness. GxP Compliance: Ensure compliance with GCP, GMP, and GLP requirements, coordinating with external consultants for technical depth. Oversee vendor and CRO quality compliance, including audits, qualification, and ongoing monitoring. Review and approve quality-related documentation (e.g., protocols, reports, batch records, SOPs, deviation/CAPA reports). Quality Systems Management: Manage internal quality systems, including document control, training, deviation management, and CAPA. Drive implementation of phase-appropriate policies, procedures, SOPs, and risk assessments to support clinical trial operations and CMC activities. Facilitate internal training and promote a culture of compliance and quality across the organization. External Oversight & Partnerships: Serve as liaison with external QA consultants, ensuring effective and efficient use of their technical expertise. Collaborate with CROs, CMOs, and other vendors to maintain high-quality standards and resolve quality-related issues. Contribute to regulatory submissions by providing QA review and ensuring compliance with applicable guidelines. Why Join Latigo
Opportunity to build and shape QA in a fast-paced, innovative clinical-stage biotech. Direct impact on the development of transformative, non-opioid therapies. Collaborative, science-driven environment with room for professional growth.
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Fast-acting, relentlessly agile, and mission-oriented Bachelor’s degree in life sciences or related field. Advanced degree preferred. 7+ years of experience in Quality Assurance within the biopharmaceutical industry, with a focus on clinical-stage development. In-depth knowledge of GxP regulations (FDA, EMA, ICH). Experience in both GCP and GMP Quality preferred. Strong track record managing QA systems, vendor oversight, and regulatory inspections. Ability to work independently in a lean environment, balancing strategic oversight with hands-on execution. Strong communication, leadership, and organizational skills with the ability to influence cross-functional stakeholders. Key Responsibilities
Quality Leadership & Oversight: Develop, maintain, and continuously improve the company’s Quality Management System (QMS) in alignment with clinical-stage regulatory expectations. Partner with the Program Teams to integrate Quality into overall development strategy and decision-making. Act as the primary point of contact for internal QA matters and regulatory inspection readiness. GxP Compliance: Ensure compliance with GCP, GMP, and GLP requirements, coordinating with external consultants for technical depth. Oversee vendor and CRO quality compliance, including audits, qualification, and ongoing monitoring. Review and approve quality-related documentation (e.g., protocols, reports, batch records, SOPs, deviation/CAPA reports). Quality Systems Management: Manage internal quality systems, including document control, training, deviation management, and CAPA. Drive implementation of phase-appropriate policies, procedures, SOPs, and risk assessments to support clinical trial operations and CMC activities. Facilitate internal training and promote a culture of compliance and quality across the organization. External Oversight & Partnerships: Serve as liaison with external QA consultants, ensuring effective and efficient use of their technical expertise. Collaborate with CROs, CMOs, and other vendors to maintain high-quality standards and resolve quality-related issues. Contribute to regulatory submissions by providing QA review and ensuring compliance with applicable guidelines. Why Join Latigo
Opportunity to build and shape QA in a fast-paced, innovative clinical-stage biotech. Direct impact on the development of transformative, non-opioid therapies. Collaborative, science-driven environment with room for professional growth.
#J-18808-Ljbffr