Manager, Quality Systems - San Diego California

Company: Initial Therapeutics, Inc.
Location: San Diego, California
Posted On: 05/04/2025

Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.SummaryThis position will contribute to the development and implementation of the company's Quality Management System.Responsibilities

• Provide quality oversight and administration of the company's document management and training systems.
• Ensure compliance with regulatory and quality standards by administering the vendor qualification and audit programs.
• Facilitate continuous improvement initiatives for the quality systems.
• Perform other related duties as assigned by management.Controlled Documents
  • Maintain a controlled document management system compliant with industry regulations (e.g., GxP quality systems, FDA/EMA, and ICH Q10).
  • Ensure document control procedures align with company policies and regulatory requirements.
  • Oversee the organization and retention of documentation and records to support clinical manufacturing.
  • Oversee document lifecycle management, including creation, revision, approval, distribution, and archival of Standard Operating Procedures (SOPs), policies, work instructions, and other controlled documents.
  • Serve as the primary administrator for the electronic document management system (Veeva Quality Docs).
  • Administer the document repository aspect of the document management system to assist with retention of analytical, manufacturing, clinical, and other GxP related documentation.Training
    • Oversee and manage the company's GxP training program to ensure employee competency and compliance with regulatory requirements.
    • Maintain training records and documentation in compliance with GxP requirements.
    • Coordinate and facilitate onboarding and ongoing training sessions for employees, ensuring alignment with company objectives.
    • Partner with department heads to identify training needs and develop role-specific training programs.
    • Evaluate training effectiveness and make necessary improvements to enhance employee performance and regulatory compliance.Audits
      • Assist with the administration of the vendor qualification program and maintenance of vendor files.
      • Assist in the development and maintenance of annual audit plans and tracking to ensure audit activities are completed according to plan.
      • Track and monitor internal and external audit non-conformances.
      • Support internal and external audits and regulatory inspections by providing relevant documentation and training records.Change Control
        • Support the management of the internal change control program to ensure changes are sufficiently documented and assessed.Computer Systems (GxP)
          • Provide Quality support and participate in IT project teams to ensure deployment of GxP systems meets relevant regulations, such as 21 CFR Part 11 and Annex 11, and that systems are qualified and maintained in a validated state.Compliance and Continuous Improvement
            • Ensure adherence to Good Documentation Practices (GDP).
            • Stay up to date with regulatory changes and industry best practices to enhance document control, training processes, and other quality related systems.
            • Lead continuous improvement initiatives related to Mirador quality systems.Quality Systems and Metrics
              • Contribute to the development and maintenance of the CAPA, deviation, change control, and product quality complaints systems.
              • Support the establishment and reporting of Quality metrics. Monitor, analyze, and report key quality metrics to management, making recommendations for corrective actions and improvements where necessary.Experience and Qualifications
                • Bachelor's degree required.
                • 5 or more years of experience in Quality or Quality-related roles such as document management, training, quality systems in the biotech and/or pharmaceutical industry.
                • Experience with internal audits and health authority inspections (GCP, GMP, GLP).
                • Experience with managing electronic document management systems (EDMS) and learning management systems (LMS).
                • Experience with Veeva is a plus.Skills and Abilities
                  • Strong knowledge of GMP, SOPs, and quality system processes.
                  • Excellent organizational skills and ability to review processes or procedures and manage multiple complex projects/tasks at the same time.
                  • Excellent written and oral communication skills.
                  • Highly proficient using Microsoft Word, Excel, PowerPoint, SharePoint, MS Teams, and electronic document management systems (such as Veeva) or similar applications and systems.
                  • Working knowledge of quality systems and regulatory requirements.
                  • Demonstrated working knowledge in areas such as document management, document change control, and audits.
                  • Ability to prioritize tasks, collaborate with employees, contractors, and vendors.
                  • Highly self-motivated and self-managed; ability to work independently and as part of a team with minimal coaching or supervision.
                  • Comfortable in a fast-paced company environment with minimal direction and able to adjust.
                  • A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect.
                  • Travel, up to 5%, depending on business need.The expected base pay range for this position is $125,000 - $165,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience, and relevant education or training. This range may be modified in the future.
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