you looking for a patient-focused company that will inspire you and support
your career? If so, be empowered to take charge of your future at Takeda. Join
us as an Oncology & Biologics Quality Compliance Specialist III in our Cambridge,
everyone matters and you will be a vital contributor to our inspiring, bold
mission. As an Oncology
& Biologics Quality Compliance Specialist III working on the Quality Compliance team, you will be empowered to works cross-functionally
with other departments, Takeda Alliance Partners and Affiliates to ensure
thorough investigation plans are developed and executed for timely and compliant
closure. A typical day will
- The Oncology & Biologics Quality Compliance Specialist III will
be responsible for coordinating/performing assigned investigations including
drafting excursion reports for review.
- Oncology & Biologics Quality Compliance Specialist III is
responsible to participate in assigned project teams as Quality Compliance lead
- Responsible for drafting and
implementing SOP s, Work Practices, Quality Agreements as they pertain to
product complaint investigations and other documents as assigned.
- Responsible for managing own workload
from multiple project managers to meet deadlines.
- Product Complaint System Oversight will
include the following:
- Performs and/or
coordinates the receipt, processing, monitoring and reporting of product
- Addresses and
expedites product complaints under the company s product complaint policy and
procedures, and ensuring compliance with federal regulations.
- Log and maintain
currency of product complaint documentation utilizing the product complaint
- Coordinate the
activities required to investigate and close Commercial product complaints,
which includes following-up with Takeda s contract call center and/or
complainants, and facilitating cross functional product complaint sample
inspections and analyses by applicable Takeda departments and Alliance
- Author and send
Commercial complainant responses per established procedures and timelines.
- Monitor and analyze product complaint
data for trends, ensuring that appropriate corrective action plans are
developed and routine status and trending reports are distributed to
- Escalates to management (as applicable),
any identified risks, improvement opportunities and/or compliance concerns
associated with the product complaint system. Provides suggestions to
appropriate company authorities to modify existing manufacturing or packaging
processes based upon pattern and related analyses.
- Co-facilitates periodic review meetings
between Pharmacovigilance, Medical Affairs, Commercial Operations and Quality
per Takeda procedures to ensure consistency of processing and reconciliation of
product complaints and adverse events.
- May attend weekly Case Review Meetings
(routinely) and Signaling Meetings (when applicable as backup), providing input
on behalf of Commercial Quality Operations
- Provide support for regulatory
inspections and GMP audits
- Responsible for engaging in regular
contact with external organizations and Takeda Affiliate Offices.
- Serve as cross-functional Lead
representative and is responsible for independent technical and non-technical
EDUCATION, BEHAVIORAL COMPETENCIES AND
- BS and
4-6 years experience with 2 in Quality Assurance/Quality Complaince or related
compliance experience or MS and 2+ years Quality Compliance experience.
Experience may be substituted for degree.
- Solid understanding of applicable
regulations and guidances. Demonstrates expertise of department processes,
tools and methods.
- Good interpersonal skills and ability to
work effectively and efficiently in a team environment to accomplish goals.
- Excellent verbal and written
communication skills and ability to communicate effectively with site
personnel, peers and management.
- Must have the following personal
attributes: integrity and trust, work
ethic, sound judgment, intellectual honesty, pragmatism, courage and
- Must be experienced in Microsoft Office
applications, especially Word, Excel and PowerPoint.
- Willingness to travel to various
meetings or client sites, including overnight trips
- Requires approximately 0-10% travel
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company
match and Annual Retirement Contribution Plan
reimbursement Company match of charitable contributions
- 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
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO
employer of minorities, women, disabled, protected veterans, and considers
qualified applicants with criminal histories in accordance with applicable
laws. For more information, visit
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