Manager, Quality Systems
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1941189
Job Description Summary
Mirati Therapeutics is seeking a highly motivated and collaborative Manager, Quality Systems to join the Quality Assurance group at Mirati. The successful candidate will support multiple functions in the Quality Management System and collaborate cross-functionally with the various Mirati GXP departments.
Reporting directly to the Director, Quality Systems, you will be responsible for ensuring our quality system meets regulations and standards. You will be integral in the development, documentation, maintenance, and improvement of the Quality Management Systems, including quality processes, procedures and controls that monitor system performance and ensures conformance to the established standards necessary to maintain quality of products and sustainable customer satisfaction.
- Develop, revise, and improve department procedures to ensure continued compliance of the quality system.
- Assist in the creation, revision, and approval of documents
- Maintain and lead Quality Management Systems including CAPAs, deviations, and change controls
- Support internal audits related to Quality Management System
- Report on the performance of Quality Management Systems to management
- Conduct Quality Management Systems training and ensure training is designed and delivered in a suitable and effective manner for the applicable audience
- Other duties, as needed
What is Required
- A minimum of a Bachelor's degree is preferred
- At least 5+ years related experience in pharmaceutical, biotech, or medical device industries, with a strong preference for experience in pharma.
- Previous experience with Veeva Vault QualityDocs and ComplianceWire is a strong plus
- Previous experience with the implementation of electronic management systems and 21CFR11 are a strong plus.
- Established working knowledge of Good Manufacturing Practices and other applicable regulations (US and international).
- Quality Assurance experience supporting both development projects and commercial products.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
- Ability to multi-task and shift priorities rapidly to meet tight deadlines.
- Professional demeanor and an excellent written and verbal communicator.
- Detail oriented and well organized.
- Good and thoughtful listener.
- Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
- Proficient in Microsoft Office suite, Adobe, and other applications.
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 KRASG12C 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 KRASG12D 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.