Associate Director, Computer Systems Validation
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1845087
Job Description Summary
Reporting to the Director, Quality Systems; the Associate Director, Computer Systems Validation (CSV) will be responsible for leading and oversight of Computer System Validation and E-Compliance programs. The position will work closely with Manufacturing, Quality, Regulatory, Engineering, and IT teams to provide QA review and oversight for GXP computer systems as well as QA support and validation oversight for implementation, validations, and system upgrades and modifications of computer systems. You will be responsible for software quality oversight and execution of system validation and verification efforts supporting computerized systems, including equipment and instruments with a computer component to ensure compliance with quality objectives and regulatory requirements.
- Provide QA and validation leadership for GxP computerized systems and apply risk-based methodology to validation and qualification efforts in compliance with 21 CFR Part 11 and EU Annex 11 or equivalent international regulations.
- Design, implement, and govern overall readiness of CSV and Data Integrity programs to ensure programs are compliant and ready for regulatory inspections.
- Oversee and execute QA and validation strategy in support of custom software systems, workflow, and analytics to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized system.
- Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party service suppliers and applications.
- Effectively identify and resolve complex system issues and appropriately communicates gating items to senior management and stakeholders.
- Provide Quality review and approval of Deviations, CAPAs, Change Controls and other quality events.
- Participate and support the external audit program for vendors related to GXP computerized systems.
What is Required
- Bachelor's Degree in Computer Science, Computer Engineering, IS, or related field required.
- Computer System Validation
- Comprehensive expertise and working knowledge of GxP, 21 CFR Parts 11, Annex 11 or equivalent international regulations, and Data Integrity compliance requirements.
- Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state.
- Proficient in problem solving, analytical skills and critical thinking
- Proficient in technical investigations, batch record review and technical writing
- Strong written and verbal communication skills.
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.