Vice President, Quality Assurance

Overview

Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in  Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.

MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets.  In the United States, MTPA launched rare disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022.  The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions.  MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.   

The Vice President, Quality Assurance provides strong strategic leadership to drive a culture of quality throughout all clinical development departments at Mitsubishi Tanabe Pharma America Inc. (MTPA). In pursuit of that goal, the Vice President, Quality Assurance assumes primary responsibility for GMP/GDP (Product QA and Investigational Product QA) quality systems, GCP & PV quality systems, the safety of clinical trial participants, the veracity of study data, compliance with related rules and regulations, and the QA-related legal protection of the company. The incumbent also drives the continuous improvement of quality systems and policies to propose optimization of the overall development process. As a people leader, the Vice President, Quality Assurance provides strategic direction and oversight of a subordinate team performing a full range of related QA activities (e.g., audits, CAPAs, deviations, inspection activities and services, QA training, internal advisory services, proper QA documentation and distribution, etc.). The incumbent also serves on the Senior Leadership Team, and in that capacity, contributes to overall strategy and planning for the business at-large.

Responsibilities

• Develops and implements short-, medium- and long-term business plans and strategies for the Quality Assurance function. As a Senior Leadership Team member, contributes to similar planning and strategies for the MTPA business at-large.
• Develops and obtains approval of QA budgets and goals for each fiscal year; prioritizes needs and manages to budget throughout the year.
• Directs and oversees the full range of QA programming including GMP/GDP (Product QA and Investigational Product QA) quality systems, clinical and PV programs, commercial activities related to PVG, QA SOPs and WIs, QA training, advisory services, Clinical Audits, Internal Process Audits, development/delivery of audit reports, etc.
• Leads the management of manufacturing sites (vendor qualification), product release, recall management, etc.
• Monitors and analyzes QA-related industry failures, particularly those impacting the quality of commercial products and investigational medicinal products, the safety of clinical trial participants, and/or study data veracity, to identify and rapidly close any similar programming gaps.
• Escalates potential quality issues to MTPC (Mitsubishi Tanabe Pharma Corporation) Global HQ in a timely manner and supports communication with regulatory agency.
• Serves as a change agent. Maintains keen awareness of developments and innovations in the pharma industry – through professional networking, conferences, etc. – with regards to QA (e.g., automation, other new technology, and new methodologies and processes). Assigns resources as required to investigate, assess, and where appropriate, develop and execute launch plans that promote continuous improvement to achieve the highest quality standards.
• Collaborates with various departments across MTPG, both regionally and globally, at the highest levels regarding Quality issues and activities, including any recent or anticipated regulatory changes. Ensures alignment on communications, lessons learned, continuous improvement achievements, and other appropriate escalations.
• Staffs, supervises, and motivates the Quality