Senior Manager, QA Record Management
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 2038657
Job Description Summary
Mirati Therapeutics is seeking a highly motivated and collaborative Senior Manager, QA Record Management to join the Quality Assurance group at Mirati. The successful candidate will report directly to the Director, Quality Systems and support multiple functions in the Quality Management System and collaborate cross-functionally with the various Mirati GxP departments to manage and maintain master documents.
- Design and implement the system and processes to protect and secure critical records and information
- Ensure all GxP records are filed appropriately in a timely manner (i.e., hard copy and electronic)
- Maintain electronic GxP records in the electronic Document Management System
- Ensure that processes and policies comply with regulatory requirements for record retention
- Responsible for off-site archival of records and ensuring accurate record retention
- Uploading records and ensuring accurate metadata for consistency of records
- Maintain files for current effective controlled documents as required
- Collaborating with other GxP functions to coordinate record archival
- Create and maintain standardized templates for essential documents
- Recognize and resolve documentation and record discrepancies to ensure consistency
- Develop, revise, and improve department procedures
- Maintain and monitor the controlled document system, including SOPs, forms, policies, and work instructions
- Support regulatory and internal audits related to record management
- Other duties as assigned
What is Required
- A minimum of a Bachelor's degree in Biology, Chemistry, or related scientific field is preferred.
- At least 8 years related experience, in pharmaceutical or biotech industries, with a minimum of 5 years in GxP-related Quality environment.
- Previous experience with Veeva Vault QualityDocs is a strong plus.
- Previous experience with the use of electronic document management systems and knowledge of 21CFR11 is 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.
- Proven problem-solving skills.
- Ability to adapt rapidly and change focus based on real time results and corporate priorities.
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.