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Job Description
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
The Global Quality Incident Management Lead manages the Quality Incident Escalation process and associated Incident support for the Global Quality Incident Management U.S. Team. You will report to the Head of Incident Management US and partner with Quality Teams across Takeda to support escalation and progression of Quality Incidents for products that are in scope of the U.S.
How you'll make an impact:
Manage Quality Incident records from beginning to end with direct responsibility for
Assist sites / incident owners with information gathering and preliminary assessments
Review incoming incident forms for accuracy and content and severity
Approve documentation to support Quality Alignment Meetings (QAMs) and those escalated to Takeda's Market Action Committee (MAC)
Oversee QAM and MAC meetings and coordinate actions; Work with Incident Owners to progress Site/Functional area investigations to support these endorsement meetings
Help with decisions before, during and after an incident is escalated and communicate with relevant functions to ensure that the incident is actioned and closed within the required timelines.
Will develop expertise in reportability of events to the FDA through FAR and BPDR submissions; Apply knowledge of FDA CFR requirements to more complex and technical situations
You will complete FAR and BPDR submissions directly to the U.S. FDA with partnership and oversight by other Quality personnel after required endorsements
Coordinate all actions coming out of the escalation and Quality Alignment meetings, including review and submission of regulatory notifications - FARs, BPDRs and drug shortage notification
Be the global lead for any Field Corrective Action resulting from the Incident
Liaison with Investigations team to develop and monitor implementation of CAPAs and other actions
You monitor performance of the Incident Escalation Process through periodic report-outs and routine metric reporting
Help compile APQRs and Quality Councils and provide data to audit teams
Manage global coordination of Field Corrective Actions (FCA), including recalls, DHPCs and market corrections.
You establish and lead FCA team and and ensure that FCA actions are carried out according to procedures.
Monitor effectiveness of recall and other actions and measure effectiveness with actual and mock recalls.
Partner with global Quality Team members on routine FDA updates to ongoing recalls.
Oversee Quality Management and Continuous Improvement of QIM process.
Business Process Management of QIM , FCA, Defect Reporting, Product Hold and Drug Shortage Notification SOPs. Ensure and monitor business process effectiveness.
Improve, through weekly team meetings, CI projects and AGILE projects.
Identify compliant solutions to improve adherence to essential Incident milestones to achieve a high level of compliance to escalation and reporting requirements across Takeda.
What you bring to Takeda:
Bachelor's degree in a relevant scientific/engineering discipline
At least 8 or more years GMP industry experience
Previous FDA experience preferred
This position excludes Colorado applicants
Our Benefits:
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
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Work Paths
Tuition reimbursement
Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.
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 observing applicable federal, state and local laws, and any other characteristic protected by law.
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.
