Join Karyopharm Therapeutics and take our Quality organization to the next level This role will set the strategy and plan and provide the leadership to further build and lead all Quality functions for the company in support of our mission to develop and provide novel cancer therapeutic products to patients globally. RESPONSIBILITIES: In this role, you will lead Quality Assurance for all GxP functions including clinical and commercial drug supply, R&D/Clinical, Quality Control, and Quality Systems for all of Karyopharm, including teams in corporate headquarters in Newton, MA, and in our R&D center based in Tel Aviv, Israel. You will be a member of Karyopharms Executive Team and will report to the Chief Business Officer and General Counsel. Build and lead a world class GCP organization responsible for oversight of multiple Karyopharm-sponsored clinical studies designed to support marketing applications globally. Lead the preparation, execution and response to regulatory inspectors worldwide, both at the company and at clinical trial sites. Oversee all GMP activities, including coordination with Pharmaceutical Sciences which comprises management of all contract manufacturing organizations globally, and all testing and supply chain activities for both clinical and commercial drug supply The Sr. VP, Quality will manage and continue to grow a talented team of over 20 Karyopharm team members to oversee all quality-related operations as well as goal setting, budgeting, hiring and development of all Quality teams globally. Own and drive the complete Quality function at a fast-paced and fast-growing pharmaceutical company with broad application of novel technologies Collaborate and interact with broad range of departments and levels of management to accomplish company objectives Manage and prioritize multiple projects and demonstrate a leadership style that can marshal the organizations most important resources to the right outcome Continue to build and scale the global Quality organization Drive and cultivate a culture of Quality throughout Karyopharm Therapeutics Collaborate cross-functionally, develop strong relationships with partners both internally and externally Set ambitious goals within Quality and in alignment with company goals Propose, review and share ownership of Pharmaceutical Sciences, Clinical Development/Operations and Quality overall goals Develop and manage the annual budgets for all Quality functions Regularly report to the KPTI Executive team, the Compliance Committee of the Board of Directors and to the full Board on the state of Quality compliance at Karyopharm Demonstrated skills and track record of building, scaling or integrating operational capabilities on a global basis in the pharmaceutical or biotechnology industry Deep knowledge of all facets of Quality Assurance (GCP, GMP, GLP, GTP), Quality Control, and Quality Systems, with a strong emphasis on GCP Experience in managing a GCP department overseeing multiple registration studies is critical Successful prior experience managing the preparation, execution and response to inspections by regulatory authorities, in particular at the sponsor A strategic thinker who can break down barriers, drive and make great decisions, and make an impact with a Quality organization Demonstrated ability to exercise judgment with the best interests of patients at the forefront Nimble and resilient to a fast-evolving small molecule drug development environment Ability to effectively communicate with inspiration, lead and influence individuals from multiple functional departments at all levels of the organization Strong organizational and time management skills to balance working on multiple projects and initiatives in parallel at a nimble, fast-paced and innovative company Strong knowledge of global regulations, in particular: U.S. and E.U. Excellent people leader with strong mentorship skills. Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment. The successful candidate will have a Juris Doctor (JD) and a Bachelors degree or higher in a scientific discipline preferred. A minimum of 15 years of experience in the industry, ideally all clinical phases through commercial drug product Ability to Travel (10%) Enthusiasm for and exemplar of Karyopharms core values: Innovation, Courage, Urgency, Resilience and Energy Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. Karyopharm Therapeutics Inc. (the \"Company\") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Companys Human Resourc es department. Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality
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