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Corporate Opportunities
PDT DD&T Quality Control Sponsor
Bannockburn, IllinoisBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
This Plasma-Derived Therapies (PDT) role will be an expert on end-to-end process of quality and regulatory plasma center operations that involve PDT Data Digital & Technology (DD&T) process including and in addition to FDA complaint, deviation, change control, protocol, IQ and HQ and center audits.
Responsibilities:
Flexible to have agile meetings with quality and product teams to discuss and improve process and issues. Work with center quality operations to monitor and keep track of center audits and keep support teams informed. Support and represent DD&T in all audits. Support and represent DD&T with all projects that have quality or regulatory component (i.e., paperless IQ, SNOW to TrackWise integration). Manage quality related support escalations that cannot be completed by support vendors. Track and coordinate the issues logged in Defect management and complaint system. Act as Business process owner for TrackWise complaint and defect tracking system. Onboard new processes and changes to support vendors. Stay up to date on regulations for plasma center and DD&T, and keep support vendors and product specialists informed. Keep track and report on KPIs. Present regularly on quality leadership calls. Train as backup to other team members.
Key Skills, Abilities, and Competencies
High attention to detail. Understanding role of IT support in regulated environment. Ability to present and organize performance data in meaningful way. Ability to successfully influence and interact with all levels and departments within PDT globally.
Complexity and Problem Solving
Ability to lead and operate independently. Understanding of when issues are out of scope of authority and when to escalate.
Internal and External Contacts
DD&T Support and Services Team, DD&T Product Teams, L1/L2/L3 support vendors. BioLife ISQA, BioLife Quality Operations, GDT global operations. BioLife center operations, BioLife Medical Affairs, BioLife Regulatory Affairs, BioLife lookback.
Education and Experience Requirements
Minimum 1-2 years previous experience providing quality and regulatory expertise working in highly regulated industry.
Previous experience supporting quality and or regulatory function in retail-oriented environment.
Experience working with and training IT managed service vendors.
Bachelor's degree required.
Desired: Experience and knowledge of ITIL processes. Knowledge of plasma collection laws and regulations.
Other Job Requirements
10% Travel
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
More about us:
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.
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
Bannockburn, ILCambridge, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeApplying Here
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3. Your First Interview
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4. Job Offer
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5. Pre-Employment
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6. Onboarding
Once you complete the pre-employment process, we’ll arrange a date for you to join the team, with an onboarding session taking place in your first few weeks at the company.
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