Job Abstract

Job ID

2024-1847

# 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 Quality Assurance Coordinator provides administrative support for the VP/head of Quality and other Quality Assurance functions. The position will contribute to all documentation activities to support quality, standards, and training within the Quality department.

• Coordinates and tracks compliance documentation according to standard operating procedures, Food and Drug Administration and International Council for Harmonization guidelines and regulations, and global regulations for the management of Quality related
• Coordinates and tracks the global and regional development and revision of Quality processes, policies, guidelines, SOPs, and training
• Coordinates and tracks applicable training documentation within Quality, other internal functions within MTPA, and any other external parties or
• Coordinates and tracks deviations and corrective and preventative actions CAPAs documentation to ensure compliance with applicable SOP/Work Instruction training for the relevant
• Coordinates and assists the inspection readiness program and inspections hosted by MTPA, internal audits, partner and affiliate audits.
• Prepares and/or assists in the finalization of a variety of high-quality correspondence, complex presentations, slide decks and reports, written agreements, memos, letters, and other
• Recommends prioritization strategies across a range of functional / corporate project-based work to meet departmental/organizational
• Coordinates and assists with compilation and tracking of Quality metrics and key performance indicators.
• Coordinates and assists with management escalation of critical product quality defects including scheduling meetings, taking meeting minutes, tracking action items to closure.
• Coordinates and assists with Quality Management Review including drafting high quality PowerPoint slides, proactively scheduling quarterly meetings with senior management, tracking action items, managing attendance logs.
• Creates, maintains and enters information into databases for tracking purposes.
• Performs general clerical duties to include, but not limited to, copying; faxing; mailing; filing; making travel arrangements; processing expense reports; processing invoices and tracking
• Maintains high level of confidentiality when handling sensitive information during the execution of departmental
• Files and retrieves organizational documents, records and
• Creates, updates and facilitates complex and busy travel itineraries of multiple
• Manages multiple Outlook calendars with expertise (staff and departments).
• Schedules, plans and coordinates a variety of events and meetings (in-house and off-site, ad hoc and recurring) which may include internal and affiliate staff members, outside consultants; duties may include booking arrangements, purchase of food, supplies and handout material, if appropriate, and recording of action
• Assists other administrative staff in scheduling and supporting meetings outside the specific department or area
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.
• Performs other departmental duties as assigned.

• Bachelor’s degree in a scientific or related discipline.
• Minimum of 5 years of administrative/project management experience.
• Minimum of 3 years of experience within a regulated environment.
• Experience and working knowledge of GxP and applicable FDA laws and regulations preferred.
• Knowledge of principles and practices of organization, planning, records management and general administration.
• Ability to prioritize work assignments.
• Competency in Windows, MS Office (Word, Excel, PowerPoint) and other relevant computer software.
• Strong communication skills, verbal and written.
• Excellent organizational and time management skills.
• Exceptional attention to detail.
• Ability to work independently with limited guidance and direction.
• Good analytical and problem-solving skills.
• Ability to operate standard office equipment, including but not limited to, computers, telephone systems, copiers and fax machines.
• Ability to sit or stand for long periods of time.
• Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer.
• Carry, handle and reach for objects.
• Lift and pull up to 15 pounds.

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 offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.

The salary range for this position is $54,000 - $86,000. 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.

MTPA 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.