Vice President, Quality Assurance

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 Assurance team. Provides feedback and coaching. Identifies any skills gaps and addresses through appropriate training plans.
• Serves as an expert resource and escalation point for QA staff. Works with subordinate QA supervisors to shape the delivery of advice, QA training, and other communications provided to MTPA staff to ensure both consistency and accuracy.
• Performs other duties as assigned.
  
  

Qualifications

• BA/BS in Life Sciences is required.
• Master’s degree in Life Sciences is preferred.
• Minimum of 12 years of experience in a relevant GXP area.
• Minimum of 7 years of experience as an auditor (ideally, with US and international agency experience in healthcare).
• Minimum of 5 years of strategic planning, budgeting, and supervisory experience in QA is required.
• QA experience with medical devices is preferred.
• Brings significant subject matter expertise; up to date with current global GCP and PV Regulatory requirements regarding clinical trials.
• Highly analytical; proven ability to leverage industry expertise to take a “big picture” view and to translate that internally into an accurate identification of the company’s (and department’s) QA strengths and weaknesses, and to mitigate any vulnerabilities.
• Change agent with demonstrated ability to drive continuous improvement in QA programming.
• Excellent communication, presentation, and interpersonal skills; proven ability to integrate seamlessly into both a global and regional team.
• Diplomatic and politically sensitive to departmental structures within MTPG (the global organization).
• Strong supervisor who can motivate staff and build their resiliency, particularly in terms of nimbly adjusting to changing business needs.
• Required to travel up to 50% (mostly domestic).
  
  

Our Value Proposition

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.

MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

The salary range for this position is $325,000 - $375,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

This position is eligible to participate in our Long-Term Incentive (LTI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.