Testing Laboratory Opportunities

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Job Description

About BioLife Plasma Services

Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

OBJECTIVES/PURPOSE

• Develop and deploy Quality Systems assuring compliance to regulatory and customer requirements.
• Ensure ongoing suitability, effectiveness and improvement of quality system with senior management.
• Coordinate or support regulatory inspection activities.
• Provide proficiency within Quality related to the design and development of software medical devices and other new technology related to software.

ACCOUNTABILITIES

• Oversees management of Quality Systems: Documentation, Change Control, Corrective and Preventive Action (CAPA), Complaints, Design Control/Validation, Management Review.
• Provides IT Quality support for software applications classified as medical devices and other computerized systems ensuring they are adequately developed, validated and deployed per applicable regulatory requirements.
• Manages risk assessments for BioLife plasma collection, testing and distribution processes and BECS software devices.
• Oversees management of validation and implementation of equipment/instruments used at the BioLife plasma collection centers.
• Responsible for results in terms of product quality and conformance to regulations and corporate policies.
• Directs coordination and support of regulatory inspection activities as needed.
• Interacts with all levels of internal management as well as across functions and business units to meet business objectives.
• Identifies and manages continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability and cost improvements.
• Manages budget activities and ensures adherence to budget.
• Manages department employees to assure they are meeting performance expectations including their own development.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Extensive competence in managing and executing the Quality System specific to plasma collection.
• Proficiency in quality related to the design and development of software medical devices and other new technology related to software.
• Expertise in process validation; provides guidance to validation and implementation of equipment/instruments used at plasma collection centers.
• Excellent verbal and written communication, interpersonal and negotiation skills.

Leadership

• Integrity & Fairness
• Honesty
• Perseverance
• Positive
• Accountable
• Results Oriented
• Function as an excellent manager of self and others
• Excellent verbal and written communication, interpersonal and negotiation ability
• Strong capability to engage, communicate and work effectively with individuals of varying job levels, geographic locations, and dispositions.

Decision-making and Autonomy

• Aptitude in indentifying requirements and using risk managment for decision making and recommendation process.

Interaction

• Advises Vice President as management with executive responsibility (MWER) in the area of risk managment for a software application medical device.
• Coordinates responses with Regulatory Affairs and other Quality Systems Managers to FDA submission questions, audit/inspections and clarifications.

Innovation

• Strong technicl application and analytical skills

Complexity

• Moderates employee relations issues
• Provides direction towards technical issues with software appication medical devices balancing business expectations and compliance.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential:

• BS in Science or Engineering.
• Minimum 10 years of experience in Quality, Manufacturing or related field in the medical products and medical devices industry.
• Minimum 7 years of management experience.
• Experience with application development and implementation of quality systems required by the FDA and EU regulatory agencies.  

Desired:

• Advanced degree in Science or Engineering
• Experience within the plasma collection industry and/or laboratory operations highly desirable
• Experience within a regulatory environment for manufacture of a software application classified as a medical device

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.

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