PDT DD&T Quality Control Sponsor
Company: Biolife Plasma Services
Location: Cambridge
Posted on: May 21, 2023
Job Description:
By 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's Privacy Notice and 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.
- 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. Locations Bannockburn,
ILCambridge, MA Worker Type Employee Worker Sub-Type Regular Time
Type Full time
Keywords: Biolife Plasma Services, Cambridge , PDT DD&T Quality Control Sponsor, Other , Cambridge, Massachusetts
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