Manager, Quality Systems

Company: Mirador Therapeutics
Location: San Diego
Posted on: April 12, 2025

Job Description:

We are building a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 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.We are led by a highly talented executive team with proven experience creating best places to work. We are driven to help patients in need, foster personal and professional growth, unlock our team potential, and to deliver exceptional results.We offer competitive benefits, pay, time off, and perks!If you have a passion for being a market leader, discovering and developing disruptive therapies, improving the lives of patients, love what you do and want to help us build a next-generation and best places to work company-we want to hear from you.Mirador's commitment to values of trust, ambition, collaboration, integrity, excellence, and ownership shapes our culture of teamwork, innovation, and relentless pursuit of developing transformative precision therapies for patients with immune-mediated diseases.TRUST

• We trust each other, believing that we all have best intentions and are delivering our part of the collective vision to improve the lives of patients with immune-mediated diseases.
• We hold each other accountable, trusting that we have each other's backs.
• We trust in the process and feel empowered to address challenges knowing they are part of how we win.AMBITION
  • We think creatively, experiment fearlessly, and develop groundbreaking ideas that benefit our patients.
  • Our ambition fuels our moonshot thinking and relentless pursuit of our goals.
  • We are empowered to challenge the status quo and seek new solutions to make what seems impossible a reality.COLLABORATION
    • We show up every day knowing that every team member brings unique value and perspective to our shared vision.
    • We know that our team output is stronger than the sum of our individual capabilities.
    • We encourage active listening, open-mindedness, and constructive feedback across all levels of the organization.INTEGRITY
      • We support each other to make the right decisions and do the right thing.
      • We have a commitment to ethical conduct in all aspects of our business.
      • Our truth is driven by science and data, which we follow no matter where it leads.EXCELLENCE
        • We expect excellence in all we do.
        • We leverage diverse skills and perspectives to achieve excellence in our shared goals.
        • Individual excellence is a given; team excellence is our competitive advantage.OWNERSHIP
          • We are invested in the success and reputation of our company, taking ownership in our work with care and commitment.
          • We take accountability as a team and as individuals to ensure the right outcomes.
          • We are writing the Mirador playbook together, collaborating, executing, and seeking continuous improvement across all levels of the organization.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
              • Maintains 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
                  • Assists with the administration of the vendor qualification program and maintenance of vendor files.
                  • Assists in the development and maintenance of annual audit plans and tracking to ensure audit activities are completed according to plan.
                  • Tracks and monitors 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 team 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
                            • 5 or more years of experience in Quality or Quality-related roles such as document management, training, quality systems in 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.
                                #J-18808-Ljbffr

Keywords: Mirador Therapeutics, San Diego , Manager, Quality Systems, Executive , San Diego, California