Job Description

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Job Description

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 Compliance

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
Supplier Audits
Evaluation and Execution of Supplier Notification of Changes
Manage change controls e.g. due to necessary product/material specification changes
Supplier Monitoring
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 quality
Ensure compliance with the global audit and specification policies, guidance, standards, procedures governing Quality Auditing and Supplier Quality
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 suppliers
Promptly escalate and report all critical audit findings, critical material issues and supplier performance incidents to the appropriate persons
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 programs
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 the organization
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 suppliers
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 pharmaceutical industry.
Previous experience in pharmaceutical manufacturing and quality operations preferred.
Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections is desired
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 leadership teams
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 screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional training and development opportunities
Tuition reimbursement

Important Considerations

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 world.

This posting excludes Colorado applicants.

#GMSGQ #ZR1 #LI-MA1

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

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

This job was posted on Thu Apr 28 2022 and expired on Thu May 05 2022.

Minimum $15K /yr

$68K /yr Average

Maximum $145K /yr

Tasks

Plan and establish sequence of operations to fabricate and assemble parts or products and to promote efficient utilization.

Review production schedules, engineering specifications, orders, and related information to obtain knowledge of manufacturing methods, procedures, and activities.

Estimate production costs, cost saving methods, and the effects of product design changes on expenditures for management review, action, and control.

Draft and design layout of equipment, materials, and workspace to illustrate maximum efficiency using drafting tools and computer.

Coordinate and implement quality control objectives, activities, or procedures to resolve production problems, maximize product reliability, or minimize costs.

Communicate with management and user personnel to develop production and design standards.

Recommend methods for improving utilization of personnel, material, and utilities.

Develop manufacturing methods, labor utilization standards, and cost analysis systems to promote efficient staff and facility utilization.

Confer with clients, vendors, staff, and management personnel regarding purchases, product and production specifications, manufacturing capabilities, or project status.

Apply statistical methods and perform mathematical calculations to determine manufacturing processes, staff requirements, and production standards.

Study operations sequence, material flow, functional statements, organization charts, and project information to determine worker functions and responsibilities.

Complete production reports, purchase orders, and material, tool, and equipment lists.

Record or oversee recording of information to ensure currency of engineering drawings and documentation of production problems.

Evaluate precision and accuracy of production and testing equipment and engineering drawings to formulate corrective action plan.

Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product.

Regulate and alter workflow schedules according to established manufacturing sequences and lead times to expedite production operations.

Direct workers engaged in product measurement, inspection, and testing activities to ensure quality control and reliability.

Formulate sampling procedures and designs and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.

Implement methods and procedures for disposition of discrepant material and defective or damaged parts, and assess cost and responsibility.

Schedule deliveries based on production forecasts, material substitutions, storage and handling facilities, and maintenance requirements.

Skills

Reading Comprehension - Understanding written sentences and paragraphs in work related documents.

Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

Writing - Communicating effectively in writing as appropriate for the needs of the audience.

Speaking - Talking to others to convey information effectively.

Mathematics - Using mathematics to solve problems.

Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.

Monitoring - Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

Social Perceptiveness - Being aware of others' reactions and understanding why they react as they do.

Coordination - Adjusting actions in relation to others' actions.

Instructing - Teaching others how to do something.

Complex Problem Solving - Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.

Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.

Systems Analysis - Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.

Time Management - Managing one's own time and the time of others.

Knowledge

Administration and Management - Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.

Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.

Production and Processing - Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.

Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.

Engineering and Technology - Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.

Design - Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.

Mechanical - Knowledge of machines and tools, including their designs, uses, repair, and maintenance.

Mathematics - Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.

Education and Training - Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.

English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.