Mirador is 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. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.
Summary
This position will ensure the quality and compliance of our GMP products and programs (cell banks, drug substance / API, drug product, finished product), and is responsible for overseeing quality aspects related to contract manufacturing organizations (CMOs) and ensuring compliance with analytical testing, stability programs, and regulatory requirements.
Responsibilities
- Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Provide quality oversight and technical quality guidance to internal CMC functions and external vendors (e.g., CMO, contract test labs (CTLs), packaging / labeling).
- Maintain programs and processes to ensure high-quality products and compliance with current GMPs.
- Manage competing priorities to meet company targets and timelines.
- Perform other duties as assigned by management.
CMO / Vendors
Interact with key stakeholders to ensure sufficient support and oversight of CMOs in the areas of quality and compliance is being provided.Ensure CMOs and CTLs comply with GMP regulations and company quality standards.Review and approve master batch production records, deviations, investigations / CAPAs, change controls, specifications, analytical protocols / reports / methods, stability protocols and reports from the CMOs / CTLs to ensure defined quality objectives are met.Interface with contract manufacturers to address documentation and compliance issues.Partner with cross-functional teams to manage vendor relationships and performance.Adhere to the terms of the Quality / Technical Agreements with the CMOs and CTLs.Support quality aspects of product scale up, process improvement, technology transfer, and process qualification activities as needed.Documentation
Develop and / or revise procedures and documentation supporting product quality activities (e.g., batch review SOPs, product specification files, batch release and testing and stability tracking spreadsheets).Maintain internal and external GxP product related documentation in electronic document management system for retention.Oversee the organization and management of documentation and records to support clinical manufacturing.Assess, manage and track product related change control and ensure internal reviews are performed, as necessary.Maintain product specification files for global products.Audits
Support vendor qualification activities, including conducting or participating in CMO / CTL external audits.Support Regulatory Inspections at CMO / CTL, as necessary.Batch Reviews
Review executed batch production records and assist with GMP batch release of clinical products.Support Qualified Person batch certification process as needed to allow global clinical material release.Analytical and Stability Oversight
Review and approve analytical method validation, method transfer, and method reports.Evaluate stability protocols and reports, ensuring compliance with regulatory expectations.Oversee trending of analytical data to assess product performance and detect potential issues.Ensure timely investigations and resolution of analytical discrepancies.Collaborate with CMC and Regulatory teams to support product filings and lifecycle management.Compliance and Continuous Improvement
Ensure GMP compliance with FDA, EMA, ICH, and other regulatory authorities.Support regulatory inspections and audits related to quality systems and vendor oversight.Drive continuous improvement initiatives in product quality and analytical processes.Experience and Qualifications
Bachelor’s degree in biology, chemistry, biochemistry or a related field.5 or more years of experience in quality assurance or other quality-related equivalent role, such as quality engineering or validation in biotech and / or pharmaceutical industry.Experience with vendor management and quality oversight of CMOs and CTLs.Experience with small molecule and biologics manufacturing processes.Proficiency in reviewing analytical and stability data, method validation, and OOS / OOT investigations.Experience with external audits and health authority inspections (GMP).Experience with in vitro diagnostic devices is a plus.Experience in release of clinical trial material preferred.Experience with Veeva is a plus.Skills and Abilities
Strong understanding of GMP, ICH guidelines and global regulatory requirements.Excellent organizational skills and ability to review processes or procedures and manage multiple complex projects / tasks at the same time.Excellent communication and collaboration skills to work cross-functionally.Ability to prioritize tasks, collaborate with employees, contractors, and vendors, and work across locations and time zones.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.Highly proficient using Microsoft Word, Excel, PowerPoint, Project, SharePoint, MS Teams, and electronic document management systems (such as Veeva); or similar applications and systems.Travel, up to 15%, 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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Salary : $125,000 - $165,000
