Director, Medical Device (Combination Product) QA - Mitsubishi Tanabe Pharma

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 Director, Medical Device & Combination Product QA is responsible for quality and compliance oversight for late-stage development and new product introduction of medical device constituent part of combination products. Scope of responsibility also include business processes supporting new product introduction including risk management. This role will be the quality subject matter expert for the device constituent of combination product.

• Responsible for quality oversight of late-stage development, design transfer, and pre-market readiness activities, conforming to Medical Device (21CFR 820s) and Combination Product as per current Good Manufacturing ruling (21CFR part 4), and Device Risk
• Management (ISO 14971).
• Responsible for oversight of all quality activities that support commercialization of combination products from a systems perspective including set up of processes related to batch disposition, 3PL and specialty pharmacy oversight, complaints process set up of
• new failure modes, MDR reportability recommendations, recall, etc.
• Provide device quality engineering and quality assurance support and leadership to ensure successful quality oversight of medical device constituent of combination products.
• Represent Quality function on commercial and product/core teams supporting quality issues related to medical devices constituent of a combination product.
• Provide Quality guidance to ensure end-to-end design control principles are implemented effectively.
• Review and approve design control and device risk management documentation for regulatory filings, development, design transfer qualification and post marketing surveillance.
• As needed, facilitate translation of customer needs into critical to quality and design input/output requirements, including but not limited to chemical, physical, or performance specifications.
• As required, participate in design reviews, CAPA reviews, and ad-hoc technical reviews to evaluate deficiencies and assess impact on compliance status.
• As required, review and approve verification/validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Ensure delivery of all quality elements needed to facilitate new product launches from the affiliate that provide products directly to distribution centers.
• As needed, collaborate with cross-functional teams to assist in the development of engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
• Provide quality oversight and guidance for successful process validations and qualifications during the tech transfer process.
• Reviews and approves deviations, investigations, and corrective action/preventive action reports.
• Support evaluation of changes (component, product, process) prior to and post design transfer for impact on manufacturing process, documentation, and design control elements.
• Responsible for supplier evaluation documentation and negotiation and review of quality agreements.
• Interface with the audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable for device component suppliers, external design houses, service
• providers, and contract manufacturers.
• Actively participates and manages pre-approval inspection readiness at external sites to ensure regulatory approvals are obtained, with no delays to market entries.
• Interfaces directly/indirectly with regulatory authorities for pre-approval inspections.
• Develop and compile inputs to be presented at the Quality Management Review.
• Provide internal or external training, as needed.
• Participate in quality management system continuous improvement initiatives as well as authoring SOPs/procedures related to combination drug/device.
• Serve as SME for evaluating the impact and applicability of new device/combination product regulations.

• Minimum BS in life sciences including engineering (mechanical, biomedical and/or systems) and natural/physical science (chemistry, biology, and biochemistry)
• 12 plus years of relevant work experience, specifically in the regulated pharma/medical space within medical device or combination products with 5-7 plus years of leadership experience.
• Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485)
• Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
• Risk Management experience (ISO 1497124971, ICH Q9)
• Expert knowledge and a comprehensive understanding of device technologies preferably infusion pumps/sterile administration sets and process (e.g., injection molding, automated assembly)
• Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices.
• Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
• A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
• Ability to work in a matrix organization and effective written and oral communicator.
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, positive interpersonal skills, and ability to manage multiple complex tasks simultaneously.
• Capable of analyzing data facts and informed opinion to direct the development of effective action plans as well as the ability to problem solve without the benefit of precedent.
• Ability to understand and overcome cultural and language barriers to provide effective strategies and successful outcomes.
• Between 30 to 50% travel both domestically and internationally.

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 $155,000 - $264,000. 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.