Associate Director, Clinical Quality Assurance Auditing
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 2064891
Job Description Summary
Reporting to the Senior Director, GxP Auditing; the Associate Director, Clinical Quality Assurance Auditing will be responsible for managing the GCP and CQA (Clinical Quality Assurance) Audit function by ensuring compliance to applicable regulations, guidelines, and operating procedures. The Associate Director, Clinical Quality Assurance Auditing will coordinate and conduct CQA 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.
- Develop and implement quality audit plans and maintain CQA Audit Schedule
- Conduct and coordinate GCP compliance audits of third parties and vendors, (i.e., Routine or Non-Routine, clinical sites, contract research organizations, central laboratories) in accordance with QA (Quality Assurance) risk-based processes
- Effectively manage the CQA audit program including coordination of project allocation and ensure that all necessary project assessments, audit schedules and plans are completed and cover areas of high risk
- Escalate potential issues to regional Senior Director, GxP Auditing and Senior Director, CQA
- Assess 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 QA, regulations and auditing
- Evaluate audit findings and prepare and distribute reports to senior management
- Monitor responses to audit observations and formulate corrective action plans
- Ensure 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
- Coordinate Periodic Internal Audit Assessments
- Assist the Senior Director, GxP Auditing in hosting audits and/or inspections, ensure proper conduct of partner-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
- Manage vendor qualification audits in Veeva QMS and provide support in relation to the audit lifecycle
- Develop, revise, implement and adhere to QA department policies and procedures
- Lead, collaborate, or support QA initiatives and 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
- Bachelors or Masters degree in Life Sciences field or equivalent
- 8 to 10+ years pharmaceutical industry experience with a minimum of 4 years in Quality Assurance
- 3+ years previous clinical QA experience, conducting a broad range of audits
- Experience in CQA, experience dealing with Regulatory compliance
- Experience working with all levels of management and consulting with key business stakeholders, with an ability to influence for greater outcomes
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams
- Strong written and verbal communication skills
- Ability to multi-task and shift priorities rapidly to meet tight deadlines
- Detail oriented and well organized
- Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies
- Proficient in Microsoft Office suite and applications
- Ability to travel, post COVID, up to 30% both domestically and internationally
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.