Director, Quality Assurance
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 2064415
Reporting directly to the Senior Director, Quality Assurance, the Director, Quality Assurance will be responsible for the quality oversight and management of all GMP-related activities, the quality management of CMOs, and strategies to advance overall company quality and compliance. This is both a hands-on and strategic quality assurance role for a small, emerging company in the targeted oncology therapeutic space with clinical assets in early and registrational phase development (based on an FDA Accelerated Approval timeframe). This key position requires a team player with a highly motivated attitude that will promote and cultivate cross-functional area support within the company to achieve and maintain the required levels of standards of quality and compliance, appropriate for the Mirati company GxP paradigm in balance with Mirati external GMP vendors.
- Manages, maintains, reviews, and approves SOPs and related process documentation for all functional areas, appropriate for the Mirati's GMP program
- Ensures internal R&D QA GMP SOPs and procedures are written, adequate and kept current in conjunction with Mirati functional areas and external GMP vendors
- Establishes GMP Policies and Standards and provides GMP training to functional areas
- Ensures Mirati GMP vendor oversight
- Reviews Quality Agreements for external vendors
- Participates in agenda setting for GMP vendor audits
- Ensures Clinical Trial Materials (CTMs) are properly manufactured and released (eg, Mirati QA Unit release function), including review and disposition of GMP products and labels, including master and executed batch records, produced at Mirati-selected GMP CMOs
- Provides QA support for review of internal documents.
- Supports the R&D project teams and reviews CMC Sections for INDs and Marketing Applications (eg, NDAs, MAAs, etc)
- Participates in mock preapproval inspections (PAIs) for Regulatory
- Assists in overseeing inspection readiness program as required
- Oversees GMP vendors during regulatory inspections as required
- Provides Regulatory submission support as needed
- Supervises direct reports
What is Required:
- Minimum of B.S. in Biology, Chemistry, Nursing, Pharmacy, or related scientific field.
- Minimum of 10 years of increasing responsibility in pharmaceutical, GxP-related Quality environment
- Proven track record of establishing, developing, and managing the quality function and implementing phase-appropriate GMP quality and compliance functions to oversee company Phase 1-3 development programs in balance with external GMP vendor
- In depth knowledge of the applicable GMP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidance; working knowledge of Computer System Validation
- Experience working with CMOs and experience with vendor selection and management
- Experience in dealing with regulatory authorities such as the FDA and other international regulatory authorities
- Auditing knowledge: understands the overall audit process including design, conduct and reporting, and corrective action follow up
- Small molecule IND through NDA experience
- Experience which includes small to medium size pharma is a plus
- Exceptional written and verbal communication skills
- Must possess the ability to effectively manage multiple projects
- Proven problem-solving skills
- Ability to adapt rapidly and change focus based on real time results and corporate priorities
- Ability to travel 10% as needed
- Management experience is a plus
- Commercialization experience is a plus
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.