Job Abstract

Job ID

2024-1849

# of Openings

1

Category

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 Parkinson's (PD).

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 diseases treatments including RADICAVA® (edaravone) injectables in 2017, EXSERVAN™ (riluzole) oral film in 2021, and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, 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 Senior Director, Quality Management System will be responsible for the design, development and maintenance of a phase-appropriate, risk-based Quality Management System, Training and Document Control programs in support of MTPA clinical and commercial business. The individual will provide Quality leadership through a cross-functional partnership with key internal and external stakeholders and will help build a robust Quality Culture.

• Establishes and maintains a phase appropriate Quality Management System consistent with the direction and business objectives of MTPA.
• Develops, communicates, and ensures implementation of the Quality Manual, Quality policy, standards, procedures and processes.
• Administers and maintains Document Control and Records Management/Archival system.
• Administers and maintains the Training and Learning Management System, deviations/investigations, CAPA, Change Control.
• Responsible for the MTPA electronic quality management (eQMS) and electronic learning management system (eLMS) to ensure they are fit for purpose and are maintained in a validated state.
• Ensures compliance with applicable MTPA policies and procedures and ensures consistency with other affiliate/global procedures and/or specifications.
• Develops, reports and presents compliance metrics and key performance indicators.
• Administers the Quality Management Review process, ensuring applicable sites report performance and system health.
• Leads and manages the escalation of critical quality defects.
• Develops and administers a compliant process for performing annual product quality reviews.
• Performs as a Subject Matter Expert in audits and inspections.
• Establishes department / individual goals, completes performance reviews, coaches, and develops employees.
• Prepares functional budget and ensures adherence to the budget.
• Drives continuous improvement and culture of Quality through self-detecting and self-correcting processes and systems and instills strong ownership and accountability.
• Provides leadership, guidance and problem-solving related to compliance matters.
• Supports the Quality Council by preparing content and driving Quality initiatives that directly impact the Quality Management System and compliance activities.
• Ensures compliance with regulatory commitments.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.
• Required to travel up to 50% both domestically and internationally.

• Bachelor’s or Master’s degree in a Scientific/Technical/discipline
  
• 15+ years of progressive experience and 7+ years in a management, or the equivalent combination of education and experience in a regulated pharmaceutical environment
  
• Demonstrated strategic planning and execution skills with ability to solve organizational problems across sites to ensure standardized application of quality system practices.
  
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a management team member and to engage and influence team members in a matrixed environment.
  
• Successful people development and leader experience with the ability to inspire and motivate direct reports at the director level and below.
  
• Ability to work independently and communicate effectively and concisely (both verbal and written) with cross-functional and cross-border stakeholders, management, and vendors.
  
• Thorough knowledge of 21 CFR 210/211/820 cGMP regulations, and applicable ICH guidelines.
  
• Excellent communication skills and a proven track record of influencing/building/promoting a culture of quality and excellence.
  
• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
  
• Ability to identify compliance risk, articulate the key relevant compliance principles, and develop actionable mitigations.
  
• Ability to author, review, and approve SOPs, policies and other controlled documentation for compliance with applicable regulations.
  
• Effective leader in a project team environment with solid emotional intelligence, problem analysis, and decision-making ability.
  
• Ability to deal with complexity, ambiguity, and multiple priorities simultaneously

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 $194,000 - $329,000. 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.