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 Associate Director, Quality Management System will be responsible for supporting and contributing to the design, development, administration, and maintenance of the Quality Management System. This position will ensure systems and processes are robust and complaint to meet the regulatory and end user needs.

Responsibilities

• Support and contribute to the implementation, administration, and maintenance of the MTPA Quality Management System and electronic Quality Management System.

• Functions as the regional eQMS administrator by maintaining permission and security roles within the system, manages licensing, reviews contracts with the vendor and managing system releases.

• Manages and maintains the QMS including defining direction and revising/authoring SOPs and Policies related to system administration, compliance, and quality processes.

• Streamlines processes and procedures to ensure enhanced user experience and compliance.

• Ensures compliance with applicable policies and procedures and ensures consistency with other affiliate and global procedures.

• Monitors the QMS processes, prioritize issues related to quality and compliance deficiencies, resolve issues and escalating when appropriate.

• Assess impact of changes associated to the quality procedures and eQMS, develop and execute plan to address changes.

• Leads QMS related activities during audits and inspections, including participation in discussions related to the QMS processes.

• Prepares content in support of Quality Management Reviews and support actions to address any improvement activities.

• Supports the process for management and escalation of critical quality issues.

• Acts as a Subject Matter Expert in audits and inspections.

• 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.

• Ensures compliance with regulatory commitments.

• Required to travel up to 25% both domestically and internationally.

Qualifications

• Bachelor’s or Master’s degree in a Scientific/Technical/discipline

• 10+ years of progressive QA experience and 3+ years in QA management, or the equivalent combination of education and experience in a regulated pharmaceutical environment

• 5+ years in administration and maintenance of a QMS

• Strong planning and execution skills with ability to identify and solve organizational challenges under limited supervision across sites to ensure standardized application of quality system practices.

• Ability to carry out difficult decisions in a logical, rational manner, and to work as a productive team member, and to engage and influence team members in a matrixed environment.

• 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 cGMP regulations. Experience with CFR 820 and applicable GCP/GLP/PV ICH Quality requirements/guidelines is a plus.

• 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 high quality 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 $150,000 - $190,000. 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.

Job Locations US-NJ-Jersey City

Job ID 2025-1921

# of Openings 1

Category Quality Assurance

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.