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Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Supplier Quality Specialist II in our Brooklyn Park, MN office.
Here, you will be a vital contributor to our inspiring, bold mission.
OBJECTIVES:
Provide support to Brooklyn Park site and functional areas for supplier performance management.
Implement a risk-based approach to supplier quality management and performance management of suppliers.
Act as key contact for Brooklyn Park site and functional areas for supplier quality management.
Implement the performance management program for all suppliers with applicable metrics, escalations and routine monitoring.
ACCOUNTABILITIES:
Create and review supplier management and audit activities within Takeda to include
Supplier Change Notifications
Quality Questionnaires
Quality Agreements
Supplier Certification
Monitor and report Supplier Performance metrics
Work with Supply Chain personnel to address vendor and material changes and support implementation
Work with Vendors and functional areas to address non-conformances related to materials
Review deviations, investigations, and CAPAs associated with cGMP compliance. Supports change controls related to Quality topics.
Investigate material issues as a Deviation/CAPA Owner.
Own and drive change controls for implementing supplier change notices and other material/supplier changes.
Support the implementation of the global system to enable consistent and effective performance management, monitoring and reporting
Support the implementation of and maintain global audit policies, guidance, standards, procedures governing supplier quality management activities
Coordinate with local team to prioritize and complete activities for supplier quality management to support the business
Receives minimal supervision on routine work assignments. Receives specific instruction on new assignments.
Identifies and proposes Quality Process and system improvements.
Critically assess issues that arise and propose solutions.
Drive decisions through use of decision-making tools/frameworks.
Complete mandatory training within required time frame.
Perform additional duties as assigned.
Support Due Diligence activities providing subject matter expertise to enable decision making; identifying quality related risks to projects
Support external engagement activities globally (community of practice) and operationally for Supplier Quality Management
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
BA/BS (or Master's) in any Life Science discipline preferred, and/or 3-5 years’ experience in Regulated (food, medical device, or pharma/biotech) industry.
Understands and applies good working knowledge of quality and GMP principles.
Familiarity or experience with the following is preferred: Auditing; basic statistics; Internal / External Auditing; Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, root cause analysis); Supplier Quality; Technical Writing and Review; Writing/reviewing/approving investigations
Ability to handle multiple tasks concurrently and in a timely fashion.
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 be able to read, write and converse in English.
Must display eagerness to learn and continuously improve.
Positive work attitude that supports teamwork and continuous improvement.
Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint. Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
LICENSES/CERTIFICATIONS:
Certified Quality Auditor (CQA) a plus
PHYSICAL DEMANDS:
Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time.
Frequent wrist and hand motion (e.g. typing, writing)
TRAVEL REQUIREMENTS:
Willingness to travel to various meetings, including overnight trips.
Requires approximately 0-5% travel.
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
