Senior Director, GXP Auditing
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1755469
Job Description Summary
Reporting to the Head of Quality Assurance; the Senior Director, GXP Auditing will be responsible for managing the GXP Audit function by ensuring compliance to applicable regulations, guidelines, and operating procedures. The Senior Director, GXP Auditing will plan and conduct GXP audits, assess audit findings, and prepare and distribute reports of findings to senior management and contracted vendors as appropriate. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.
The Senior Director, GXP Auditing will have the following responsibilities. These may include but are not limited to:
- Develops and implements quality audit plans and maintains GXP Audit Schedule
- Conducts and/or coordinates GxP compliance audits of third parties/vendors, (i.e. Routine or Non-Routine, pre-clinical, toxicology sites, clinical sites, manufacturing sites, etc.) in accordance with QA (Quality Assurance) risk-based processes
- Assesses compliance of vendors processes against ICH (International Conference of Harmonization), applicable government agency regulations/ guidelines, as well as company policies, procedures and industry standards; applies comprehensive working knowledge of Quality Assurance, regulations and auditing
- Evaluates audit findings and prepare and distribute reports to senior management
- Monitors responses to audit observations and formulation of corrective action plans
- Ensures corrective actions are taken to bring QA observations to closure as applicable
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
- Coordinates Periodic Internal Audit Assessments
- Assists the Head of Quality in host audits and/or inspections; Ensures proper conduct of partner-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
- Manage vendor qualification audits in Veeva QMS and provides support in relation to the audit lifecycle
- Develop, revise, implement and adhere to Quality Assurance department policies and procedures
- Lead/collaborate/support in QA initiatives/projects for quality, process improvements
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
- Other duties as assigned
What is Required
- Bachelor's Degree in Chemistry, Engineering, Biology, Manufacturing Management, or related scientific discipline required.
- 12+ years of experience in pharma/biopharma industry required.
- 4+ years previous clinical/nonclinical Quality Assurance experience conducting a broad range of audits.
- 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 KRAS G12C 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 KRAS G12D 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.