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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.

Videos

  • Medicine for the World

  • Inspired by Patients

  • Corporate Citizenship Activities

News and Events

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 an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

BioLife is an industry leader in operating high-quality plasmapheresis centers throughout the United States. At BioLife Plasma Services, we excel at caring. Caring for the quality of our lifesaving services, caring for the donors who help make it happen, and caring for the communities we call home. Improving Lives. Improving life for everyone.

BioLife’s employment opportunities are among the best, offering competitive pay, immediate benefits, paid time off, on the job training, advancement potential AND an environment full of fast-paced fun all while working to save lives.

Primary Role as Quality Management Support
Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Takeda Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised.
All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.

Center Quality Assurance Oversight: (65%)
Provide on-site support of Center Quality needs
Serve as a Subject Matter Expert (SME) by maintaining a high level expertise in current regulatory requirements.
Provide training and coaching to local and other employees as relevant on quality related matters.

Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Work closely with Plasma Center Management and other internal groups to perform the assessment and influence necessary actions.

Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans.

Works in collaboration with center manager and management team to prepare for internal auditors and external inspectors.
Provide new center inspection support and review inspection summaries.
Assists center management teams to ensure timely closure of audit observations.
Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements.

Regulatory Compliance: (15%)
Stays current with all federal, state, local and company-specific rules, regulations, and practices.
Ensures Plasma Center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety.
Assesses and ensures compliance for new center licensure.
Ensures that SOP’s are current and that staff perform routine tasks according to SOP through direct observation.

Continuous Improvement: (20%)
Identifies potential SOP revisions as needed to support continuous improvement for Quality Operations Training
Collaborates with cross functional work teams to identify quality improvement opportunities as they related to Plasma Center Development.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note the percentage of time spent on each job duty is an estimate for normal operating conditions.

Key Skills and Competencies

Minimum of one year relevant work experience, or an equivalent combination of education and experience. Relevant work experience within medical or regulated field, highly desirable.
Previous work experience within the plasma collection industry is strongly preferred.
Computer skills in word processing, excel, data analysis and databases highly desirable.
Demonstrated understanding of quality assurance in an FDA-regulated environment.
Demonstrated understanding of plasma center operations.
Effective organizational, technical and problem solving skills.
Reports to Associate Quality Assurance Director (Internal)
Consults and coordinates directly with the Center Management, Quality Management and Regional Management on quality concerns within a plasma center.
Advises and coordinates will all other center roles to effectively problem solve, mitigate risk, ensure safety of staff and donors, and provide an exceptional customer experience.

Other Job Components
Complexity and Problem Solving
Responsible for providing guidance and expertise to Center and Quality Management teams
Refers to Associate Quality Assurance Director for guidance on complex, high-impact or urgent decisions (internal)
Responsible to collaborate with cross-functional Quality Operations Team members on decisions impacting Center Development
Internal and External Contacts
Reports to Associate Quality Assurance Director (Internal)
Consults and coordinates directly with the Center Management, Quality Management and Regional Management on quality concerns within a plasma center.
Advises and coordinates will all other center roles to effectively problem solve, mitigate risk, ensure safety of staff and donors, and provide an exceptional customer experience.

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 SR0031029

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