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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 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.

As a Senior Director of Quality Assurance CMC, you will be responsible for providing operational leadership and oversight of MTPA clinical and commercial programs ensuring compliance with applicable regulatory requirements and other relevant regulations. More specifically, the individual will work with the global cross-functional CMC team executing late-stage development in support of Phase III clinical trials, launch readiness, and commercial quality activities primarily within the US and Canada markets. Additionally, the role will be supporting the VP of Quality in building the organizations strategy and vision.

Responsibilities

• Function as the technical subject matter Quality expert and provide leadership and oversight for all matter related to GMP regulations and guidelines in relation to manufacturing, packaging/labeling/serialization and distribution of small molecule and combination drug device products.

• Accountable for product disposition of clinical and commercial lots for small molecule and combination drug device.

• Lead and manage Quality aspects of product shortage and complex product related investigations, field alerts and product recalls.

• Collaborate with, communicate with, and provide Quality oversight of external service providers or suppliers directly involved in the drug development/manufacturing process.

• Prepare KPIs and present during business review meetings.

• Manage the review and approval of change controls, deviations, investigations, CAPA, and Product Quality Complaints.

• Lead and execute the annual product quality reviews.

• Lead and or participate in risk assessment and implement appropriate quality and process controls to ensure proper oversight of all production activities.

• Negotiate complex clinical and commercial Quality Agreements for CMOs, CPOs, 3PLs, Specialty Pharmacies, alliance partners, affiliates to meet quality operation and compliance requirements.

• Review and approve specifications affecting product quality and oversee the development of master batch records.

• Review and approve master validation plans, validation protocols, risk assessments/FMEAs, validation reports.

• Review and approve tech transfer protocols, reports and executed batch records.

• Support vendor qualification program, review written reports, follow up to resolve findings, and monitor vendor performance.

• Manage the resolution and communication of critical Quality and compliance events.

• Develop Quality metrics and key performance indicators.

• Prepare and present in Quality Management meetings such as Material Review Board, Change Control Board, Quality Escalations and Quality Management Review.

• Review CMC sections of NDAs and lead/participate in strategizing/resolving activities related to the resolution of requests from the regulatory agencies.

• Function as the CMC QA subject matter expert during regulation inspections.

• Participate in the site inspection readiness program.

• Support internal audit program by hosting the auditor and addressing observations within timelines.

• Lead/participate in internal and external project team meetings.

• Author CMC QA SOPs and support QMS for clinical and commercial products.

• Participates in continuous improvement initiatives to accomplish compliance, productivity, cost-effectiveness, and enhanced efficiencies of processes and procedures as they pertain to quality.

• Manage, develop, and mentor QA CMC team including establishing department goals and performance reviews.

• Position requires travel between 30 to 50% domestic and international.

Qualifications

• Bachelor’s or Master’s Degree in Biology Chemistry, Chemical Engineering or related fields”

• 15+ years of progressive GMP/CMC Quality Assurance experience with 7+ years in management, or the equivalent combination of education and experience in a regulated pharmaceutical environment.

• Demonstrated strategic planning and execution skills with ability to make sound and timely quality decisions when faced with complex compliance, technical, supply, and regulatory considerations

• 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.

• Strong understanding of small molecule manufacturing and combination drug device and experience with new product launch and vendor oversight/management

• 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.

Job Locations US-NJ-Jersey City

Job ID 2024-1852

# 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.