Associate Director, Product Complaints
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1842520
Job Description Summary
Reporting to the Head of Quality Assurance; the Associate Director, Product Complaints will be responsible for providing oversight of global product complaint handling and reporting including investigations, proactive reporting-trending-surveillance, and CAPAs for Product Complaints (PC) in conformance with current standards and procedures and ensures escalation of product issues by collaborating with multiple functional areas including Medical Affairs, Technical Operations, Regulatory Affairs, Drug Safety, Commercial and Quality. Continually seek out ways to enhance customer service experience both internally and externally.
- Develop, design, and implement Product Complaints program and processes; optimize procedures to ensure timely and accurate receipt, logging, analysis and response to complaints and reportable events.
- Ensure oversight of complaint trending through quarterly review boards and collaboration with Drug Safety to investigate signals that may indicate product issues.
- Assure and maintain regulatory compliance of the complaint program.
- Author and perform periodic reviews of program-related SOPs and revise as necessary
- Lead complex customer and product complaint investigations and reports
- Develop risk management strategies and coordinate end-to-end reporting process.
- Define, track, and measure metrics / Key Performance Indicators
- Maintain and monitor metric dashboard for product complaint investigations including data collection and analysis to ensure on-time completion.
What is Required
- Bachelor's Degree. Biology, Biochemistry, Chemistry, Engineering or related field required.
- working knowledge of Quality processes and systems
- 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.