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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.
• 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.
• Keeptrack and report on KPIs. Present regualary on quality leadership calls. Train as backup to other team members.

Education and Experience Requirements

• 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. Four year degree.

• 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.

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