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Job Description
About the Role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Sr Manager, GRA Labeling Quality where you will partner with internal stakeholders and external CRO partners such as Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE (safety), Regulatory Therapeutic Areas, Local Operating Companies, and Supply Chain on all matters related to labeling compliance. As part of the GRA Labeling Quality team member, you will report to the Sr Director, Global Labeling GRAD
How You Will Contribute:
- Ensures clear and timely communication about labeling compliance activities with stakeholders.
- Manages activities related to compliance of labeling events and end-to-end tracking of labeling events.
- Escalate issues/problems to management as needed.
- Maintains strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory Affairs and labeling.
- Supports evaluation and investigation of Quality Events, including conducting root cause analyses and develops corrective and prevention action plans.
- Identifies and proposes process improvement opportunities and solutions.
- Supports other labeling compliance activities as required.
- Responsible for demonstrating Takeda leadership behaviors.
- Drives compliance to labeling processes, labeling content, and adherence to KPIs and timeliness indicators.
- May present or support audits and inspections related to global and regional labeling processes and compliance.
- Supports investigations into labeling quality events and ensures that corrective and preventative actions are appropriately identified and completed.
- Escalates issues/problems to Labeling Compliance management as needed.
Technical/Functional (Line) Expertise:
Knowledge of business area and regulatory environment and ability to identify and proactively manage the interactions necessary for achieving business goals and objectives. Awareness of global health authorities, regulations, product approval, labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices. Excellent analytical, technical, and problem-solving skills (TQM or Six Sigma experience preferred). Project management abilities.
Leadership:
Comfortable working across functions, regions, and cultures. Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing. Ability to distill complex issues and ideas down to simple comprehensible terms. Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
Minimum Requirements/Qualifications:
- Bachelor’s degree (or equivalent) required. Masters preferred.
- 5+ years experience in Pharmaceutical or Medical Device industry, with 3 years in Regulatory Affairs, labeling or quality assurance/compliance.
- Systems Knowledge –knowledge of Quality Management Systems, including EDMS, and Deviation (Trackwise) systems.
- Regulatory Familiarity –awareness of European, US and international regulations relative to labeling.
What Takeda Can Provide
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Massachusetts – Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
