Associate Director, Quality Metrics
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1755458
Job Description Summary
The Associate Director, Quality Metrics will report directly to the Head of Quality Assurance. This individual will be responsible for the development, execution, and implementation of the Quality Metrics program at Mirati. The Associate Director, Quality Metrics will ensure that all aspects of the operational business (including contracted vendors) comply with cGMP regulatory requirements (US/EU/ROW), the Mirati Quality Manual and Policies, and site procedures. The ideal candidate will have a strong quality assurance and quality systems background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required.
Reporting to the Head of Quality Assurance, the Associate Director, Quality Metrics will have the following responsibilities. These may include but are not limited to:
- Develop, execute, and implement a robust and compliant Quality Metrics program which meets all regulatory requirements and according to Mirati Corporate Quality Manual and relevant SOPs.
- Establish internal process for collection of data and information flow from all key quality systems and sources. This also encompasses relevant CMO data and information.
- Author and present quarterly quality metrics reports to senior management. This includes data interpretation of analytical, manufacturing, compliance and regulatory data and drawing conclusions from data.
- Verify the consistency of existing processes and highlight any trends. Provide a documented review of key quality indicators with support of SMEs to determine the need for changes in product or process specifications, manufacturing, or quality procedures and ensuring alignment with filing.
- Establish review and verification process with key SMEs for the evaluation of trends and determination of CAPAs for inclusion in quarterly metrics reviews.
- Ensure follow-up and closure of all CAPAs identified and linkage to other quality systems (e.g. Deviation trending reports, etc.)
- Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Mirati's standard processes and quality systems.
- Manage multiple projects and ongoing work activities within the function typically involving cross-functional representatives.
- Complete annual assessment of health of Mirati Quality Metrics Program
- Interface with Regulatory Agencies in audits, track, and report metrics for all internal auditing activities.
- Other duties as assigned.
What is Required
- Bachelor's Degree in Chemistry, Engineering, Biology, Manufacturing Management, or related scientific discipline required.
- 8-10+ years of experience in pharma/biopharma industry required.
- Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance.
- Experience in problem solving, process improvement, negotiations and supervision.
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.