Sr. Supplier Quality Associate
Company: Takeda Pharmaceutical
Location: Social Circle
Posted on: May 16, 2022
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As the Sr. Supplier Quality Associate, Supplier Quality Management,
you will drive the execution of the global Supplier Quality and
Material Management programs at the Social Circle, GA Takeda site.
You will execute qualification, maintenance and monitoring for the
plant's suppliers, with an emphasis on continuous improvement,
global alignment, risk management and supply chain reliability. You
will report directly to the Associate Director, Quality
How you will contribute:
Partner with the business and key stakeholders to drive continuous
improvement in Quality performance across the plant and the
company, to understand priorities and align on expectations.
Supporting local cross functional partners and stakeholders in the
Plasma Operations on matters about supplier controls, concerns
related to Quality System performance, risk-based audit execution,
issue escalation, procurement strategy and regulatory compliance
issues, resolves and mitigates Supplier Action Reports (SARs)
issued to supplier for a nonconforming material.
Implement global supplier and material/product management and audit
activities for the suppliers assigned locally:
Build relationships with the locally assigned suppliers
Create and maintain local product / material specifications
Solving of material related issues in cooperation with impacted
production departments or Quality Control and suppliers resp.
manufacturers around the globe (Material Deviations, CAPAs)
Supplier Qualification and maintenance / Quality Agreements
Evaluation and Execution of Supplier Notification of Changes
Manage change controls e.g. due to necessary product/material
Execute the strategic direction and oversight of external auditing
and supplier quality and material management to achieve sustained
success for regulatory inspections and supply chain product
Ensure compliance with the global audit and specification policies,
guidance, standards, procedures governing Quality Auditing and
Support the coordination with Global Supplier Quality management
group and global audit planning / scheduling group to assign lead
auditors and co-auditors to perform audits for critical local
Promptly escalate and report all critical audit findings, critical
material issues and supplier performance incidents to the
Perform external audits
Support Due Diligence activities worldwide providing subject matter
expertise to ensure decision-making; identify quality related risks
to projects and the provision of resolutions
Execute the Supplier Qualification and Product/Material
Specification program requirements per schedule
Provide performance metrics to drive continuous improvement of the
Manage performance management and risk identification for suppliers
and resolution of incidents
Ad-hoc participation with Quality Auditing
Understanding of relevant regulations ensuring partnerships across
Partner with Production departments and Quality Control to support
our priorities from a supplier quality perspective
Partner with Procurement on Supplier Quality Management processes
and individual suppliers
Interact on a routine basis with external partners and
The complexity of this role relies in the diversity of
manufacturing techniques and suppliers, and the connection to the
global team and other Takeda sites.
What you bring to Takeda:
Bachelor's degree Sciences or Engineering or related field with a
minimum 5 years of experience in the biotechnology, biologics, or
Previous experience in pharmaceutical manufacturing and quality
Experience working with regulatory agencies and/or direct interface
experience with regulatory agencies during inspections is
Experience of biologics or pharmaceutical manufacturing
Understanding of local and global regulations
Able to present important quality concepts to senior
representatives, external business partners and internal senior
Competent in Word, Excel (can perform complex functions),
PowerPoint and SharePoint
Up to 10% travel
What Takeda can offer you:
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
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs and company match of charitable
Family Planning Support
Professional training and development opportunities
At Takeda, our patients rely on us to deliver quality products. As
a result, we must follow strict rules in our manufacturing
facilities to ensure we are not endangering the quality of the
product. In this role, you may:
Must be able to lift, push, pull and carry up to 15 lbs.
In general, you will have a combination of sedentary work and
walking around observing conditions in the facility.
Will work in controlled environments requiring special gowning, as
necessary. Will follow gowning requirements and wear protective
clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial
fingernails may be worn in the manufacturing environment.
Will work in a cold, wet environment, as needed.
Some Clean Room and cool/hot storage conditions.
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
This posting excludes Colorado applicants.
#GMSGQ #ZR1 #LI-MA1
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.
USA - GA - Social Circle - Hwy 278
Keywords: Takeda Pharmaceutical, Athens , Sr. Supplier Quality Associate, Other , Social Circle, Georgia
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