Testing Laboratory Opportunities

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Job Description

The Quality Systems Manager is responsible for the oversight and management of various quality systems or functional areas in the laboratory in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable BioLife policies, and quality initiatives.  The Quality Manager plans and coordinates activities to manage areas of responsibility by performing the following duties personally or through subordinates within the Quality organization.

ACCOUNTABILITIES

• Manage the activities of specific functional areas within the Quality organization (may include Quality Systems, Document Control and other areas as assigned) with responsibility for results in terms of product quality, conformance to regulations, and Takeda quality policies.

• The manager may be responsible for various functional areas and supervise/manage day to day activities of the quality systems team.

• Implements quality system procedures and manages compliance to quality and regulatory requirements.

• Evaluates laboratory systems, processes, procedures and equipment as they relate to established regulatory and quality requirements.

• Prepare for and participate in FDA, CLIA, EMEA, BioLife and other inspections.

• Manages internal quality assurance audits to evaluate laboratory systems to ensure compliance and quality.

• May participate in assessments of suppliers to analyze compliance and assess risk.

• Interacts frequently with subordinate supervisors and functional peer group managers.

• Identifies and manages continuous improvement projects to improve quality systems and processes.

• Manages the coaching, training and development of quality systems staff.

• Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence goals (including but not limited to 5S, Value Stream Mapping and Kaizen.

• Provides leadership in problem identification, and resolution.

• Works in conjunction with other Quality Managers, Director of Operations and Laboratory Operations Managers in the implementation, monitoring, and maintenance of laboratory quality systems.

• Other duties as assigned

Technical/Functional (Line) Expertise

• Thorough knowledge of applicable procedures, specifications, regulations and standards.

• Strong analytical and problem solving skills.

• Strong leadership skills.

• Good project management skills.

• Attention to detail and organizational skills.

• Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.

• Ability to adapt to changing priorities.

• Walking, standing, observing others performing work assignments.

• Ability to work in an office / production environment. 

• Potential exposure to blood borne pathogens requires some work tasks to be performed while wearing gloves.

• The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Leadership

• Integrity

• Fairness

• Honesty

• Perseverance

• Putting the patient at the center

• Building trust with society

• Reinforcing our reputation

• Developing the business

Decision-making and Autonomy

• Must be able to determine impact to product quality when testing deviations occur, contain the situation and implement preventive actions.

Interaction

• Interfaces with employees of various educational backgrounds and levels within the company.  Must be able to communicate effectively with all these various business partners.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology).

Desired:

Bachelor’s degree or higher from an accredited college/university in medical technology.

MT or MLT Certification preferred

Familiarity with regulated disciplines in a laboratory setting or a pharmaceutical manufacturing environment.

Five to seven years experience in a professional or technical capacity in laboratory services, quality, engineering or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.

3-5 years management experience required.

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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