Associate Director, GXP Vendor Management
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1754510
Job Description Summary
The Associate Director, GXP Vendor Management will report directly to the Senior Director, Quality Assurance. The Associate Director, GXP Vendor Management will be responsible for managing the GXP Vendor program by ensuring all Mirati vendors are qualified according to the applicable regulations and Mirati's processes and procedures. The ideal candidate will have a strong quality assurance and quality systems background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required.
The Associate Director, GXP Vendor Management will collaborate with GXP Auditing function to ensure vendors are assessed, qualified and the applicable quality agreements are in place prior to GXP use. The Associate Director, GXP Vendor Management will have the following responsibilities.
These may include but are not limited to:
- Develops and maintains the Quality Agreements Program at Mirati includes GCP, GLP and GMP vendors
- Works closely with Supply Chain, Clinical, GXP Auditing and QA Operations to identify new Quality Agreements
- Authors and ensures internal reviews (Mirati Legal, Supply Chain & Reg CMC & QA departments) and external reviews (i.e., corresponding vendor QA department) are conducted in a timely manner for all GXP Vendor Quality Agreements
- Responsible for any periodic reviews and amendments of Quality Agreements including Quality Agreements with Mirati GXP Business Partners
- Works closely with Mirati Supply Chain and third-party vendors to ensure all qualified vendors are inputted electronically in Veeva QMS and included on the Mirati Approved Vendor List
- Works closely with Quality Metrics function to periodically provide applicable vendor performance and quality metrics
- Works closely with QA Operations team and vendor QA to ensure corrective actions at vendors are completed to prevent Quality Events from recurring as applicable
- Assist in developing, revising, implementing, and adhering to Quality Assurance department policies and procedures
- Collaborate/support in QA initiatives/projects for quality, process improvements
- Other duties as assigned
What is Required
- Bachelor's Degree in Chemistry, Engineering, Biology, Manufacturing Management, or related scientific discipline required.
- 8-10+ years of experience in pharma/biopharma industry required.
- In depth knowledge of GDP and legal requirements.
- Able to work well in a matrix organization set up and influence key stakeholders.
- Able to influence indirect reports to deliver results.Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance.
- Experience in problem solving, process improvement, negotiations and supervision.
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.