Director, IT Quality & Compliance (Remote or Office based)
Department: Facilities / IT
Employment Type: Full Time
Reference Number: 2404990
Job Description Summary
Mirati Therapeutics is seeking a Director of Information Technology (IT) Quality & Compliance. This person will have a key role in shaping the design and implementation strategy of Mirati's IT Quality and Compliance vision. This position will be expected to partner with business owners, IT staff, Quality Assurance, and external service providers to develop validation / compliance strategies that meet the business need and regulatory requirements including IT related General Controls for SOX. This role will be expected to the be the IT Subject Matter Expert (SME) with respect to IT Quality, computer validation, and compliance process at Mirati Therapeutics.
- Serve as the IT subject matter expert in the development and oversight of computer system validation for Mirati Therapeutics., including establishment, adherence and operations of relevant SOPs and Policies.
- Ensure GXP computer systems are designed, validated, and operated in compliance with applicable regulatory requirements and internal procedures.
- Represent IT in internal and external audit program(s), which includes focus on 21 CFR Part 11/Annex 11 compliance and regulatory agency inspection readiness.
- Manage computer systems and controls for SOX compliance and create change management adopting ITIL standards.
- Partner with business owners, IT and QA staff to ensure projects meet deliverable timelines and requirements.
- Build and manage partnerships to drive IT Quality and Compliance across Mirati's regulated IT enterprise project portfolio.
- Partner to recommend systems for audit, write audit plans, coordinate scheduling, conduct and/or manage audit, write audit reports, close audits.
- Review and approve proposed changes and implementation plans to computer systems and procedures, as appropriate.
- Establish IT presence and oversight in software vendor qualification and compliance audit program.
- Track, review and report metric information for use in continuous improvement of areas of responsibility.
- Implement, operate, and maintain solutions with an agile delivery approach.
What is Required
- Bachelor's degree; Master's in related area would be a plus
- 15-20+ years of experience in computer software assurance and/or Validation for GXP systems and environments.
- Experience implementing SOX general controls and regulatory requirements such as 21 CFR Part 11.
- Strong knowledge of IT compliance SOPs including change control practices/strategies, and system risk assessments.
- Experience writing test plans and test case.
- Ability to conduct manual and automated testing.
- Experience with ERP, Veeva suite, or other eQMS systems preferred
- Strong knowledge of GMP, GAMP 5, SOPs, quality systems and Health Authority Regulations & Validation practices/principles.
- Experience with computer system software vendor audits.
- Experience in the pharmaceutical industry.
- Project Management experience; Understanding and practical experience of Agile
- 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.