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What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

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Engage Others Motivates and influences others to gain support for ideas, strategies and actions in service to providing superior pharmaceutical products to patients; provides appropriate background so that messages are meaningful with audiences.

Collaboration Establishes productive relationships and partners with others across the organization to ensure common understanding of objectives and achieve shared goals.

Drive for Results Holds self and others accountable for delivering on commitments that align with our short- and long-term goals, never forgetting the end result is to help patients through innovation in medicine.

Strategic Approach Makes sound decisions that are consistent with our mission, values and organizational objectives.

Lead Change Proactively evaluates, promotes, and initiates change that creates value for patients, the organization, and our shareholders.

Self Awareness Seeks feedback from others, modifies self-perceptions and actions based on this feedback, and actively develops skills and behaviors to enhance contribution.

Develop Capabilities Seeks opportunities to develop oneself and others so that we can continue to achieve sustained growth.

Rewards

  • Teamwork

    Takeda builds strong, borderless and empowered teams through fairness and promoting shared goals. By working together, we optimize energy and can lead the change for a better world.

  • Innovation

    Takeda implements bold initiatives on a daily basis by striving for continuous improvement and encouraging enthusiasm and creativity. This value speaks to attracting the best minds in the industry that are committed to delivering novel therapies to patients worldwide.

  • Diversity

    Takeda respects and includes a broad range of people and ideas in its daily operations. Our organization encourages each individual to act with empathy and to apply their unique skills to realize the company’s true potential.

  • Passion

    Takeda's drive comes from perseverance, urgency and a strong desire to contribute to patients. We put this passion to work in everything we do and demonstrate courage to fight for ideas and objectives to raise the quality of our solutions, create stronger ties with our stakeholders, and deliver results.

  • Commitment

    Takeda works to meet its responsibilities to stakeholders on a daily basis. We provide adequate support and challenge to ensure we deliver high-quality solutions that help more people around the world.

  • Transparency

    Takeda appropriately shares information and promotes honest, sincere dialogue with stakeholders to build trust. This trust enables us to strengthen our relationships with employees and external communities.

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  • Medicine for the World

  • Inspired by Patients

  • Corporate Citizenship Activities

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Overview

Takeda has maintained an unwavering dedication to put patients first for more than 235 years while we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

We focus our research and development on the core therapeutic areas of oncology, gastroenterology, neuroscience, and on providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

Responsibilities

Takeda is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest. Supervises a staff of QA Associates that are responsible for providing Quality Assurance support for Fractionation manufacturing process. Provides Quality oversight of operation activities, review batch related document will use of Electronic Batch Management (EBM) system. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices Interacts frequently with functional peer, and provide coaching, training and development of subordinates. The incumbent will be responsible to handle multiple projects, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. This position is a third shift position lDuties and Responsibilities: Plans and schedules the work of QA Associates. Support supervision for the floor coverage (as needed) and lead daily departmental operations. Supervises a staff of QA Associates to ensure compliance with manufacturing procedures are followed on the floor. Supervising the staff to ensure that production records are reviewed established targets. Provide Training and coaching for the department Work closely with Production Supervision, Other QA Operations Groups, Quality Systems, and Engineering to ensure adequacy and appropriateness of product specifications. Provide support towards engineering runs and validation activities. . Review electronic batch records, identify nonconformance’s and participate in investigation and Corrective and Prevention Action(CAPA) activities Provide training and coaching to local employees and others as needed on relevant area(s). Write, review, revise, and approve written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Oversee review and audit of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Participate in QA multi-site projects in the role of contributor, coordinator or lead. Other duties, tasks or projects as assigned. Working Environment: Will be spending large portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines. May be required to work weekends, evenings, off-hours, and extended periods of time. May be required to travel to local and international work locations for extended periods of time for training. Qualifications: Education and/or Experience Bachelor’s degree in Engineering, Science or related field or equivalent. Minimum of 4 years of QA experience in the life sciences and experience with a medical device / pharmaceutical or other similarly regulated industry preferred. Strong interpersonal/communication/influencing/negotiation skills Strong analytical and problem solving skills. Must have the ability to encourage teamwork and drive decisions. Must be able to handle multiple projects concurrently. Requires scientific and technical knowledge in the areas of manufacturing, laboratory testing, documentation and regulations Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint required Knowledge of Electronic Quality Systems( TrackWise), Process control systems (Delta V, BAS) and Electronic Batch Record Management preferred Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0029304

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