Senior Director, Clinical Quality Assurance
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1631140
Job Description Summary
Reporting to the Head of Quality Assurance, the Senior Director, Clinical Quality Assurance will lead the Clinical Quality function within the QA department and collaborate cross-functionally with the various Mirati GXP departments to ensure GCP compliance at Mirati and Mirati's approved vendors and clinical sites.
- Accountable for GCP compliance for ongoing Mirati clinical trials
- Identify compliance risks and implement risk mitigation measures where applicable
- Ensure Inspection Readiness of Mirati's clinical programs, including ensuring Inspection Readiness at Mirati's approved vendor and clinical sites as appropriate
- Work with Clinical and Medical to Assess Vendor Classification Level
- Oversight of Clinical Vendor Qualifications including, External GCP and GLP Audits, Performing Audit Assessments and Authoring and/or Reviewing Audit Reports
- Responsible for Drafting and Maintaining Current Quality Agreements with clinical vendors
- Maintain the GCP and GLP Audit Schedule (Internal & External)
- Manage internal and external GCP and GLP audits and inspections to ensure compliance with established quality assurance processes, standards, regulatory guidelines
- Ensure product complaints arising for investigational products are managed and investigated to ensure compliance with worldwide regulations for clinical trials and nonclinical studies
- Work with Regulatory to review IND submissions ensuring compliance
- Ensure clinical documentation in support of Trial Master File is archived and reviewed appropriately
- Conduct QC reviews of Clinical Protocols, IBs, and IND / IMPD Amendments
- Manage periodic GCP refresher training and SME inspection readiness training
- Develop, revise, implement and adhere to clinical QA department policies and procedures
- Develop Clinical Quality organization as appropriate to support the volume of development projects
What is Required
- Bachelors' or Masters' degree in Life Sciences field or equivalent
- 12+ years pharmaceutical industry experience with a minimum of 6 years in Quality Assurance.
- Previous small molecule drug experience is a strong plus
- Established working knowledge of Good Clinical Practices and other applicable regulations (US and international).
- Quality Assurance experience supporting all phases of clinical trials.
- 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.
- Strong communication skills both written and oral.
- 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.
- Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
- Proficient in Microsoft Office suite and 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.