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Job Description

_OBJECTIVES/PURPOSE_

The Quality Operations Manager is responsible for the quality oversight of laboratory testing operations in two lab locations 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 Takeda and BioLife policies, and quality initiatives. Manages through subordinates the coordination of the activities of the Quality Operations Organization of two lab locations. Is responsible for results in terms of testing quality and conformance to regulations and Takeda quality policies.

_ACCOUNTABILITIES_

+ Establishes and oversees quality operations to ensure accuracy and appropriate sample testing is performed, completed, and reported in a timely manner.

+ Reviews testing, quality control, process variation, equipment maintenance, and other reports to ensure that quality standards, efficiency, and schedules are met.

+ Ensures that consistent systems in both lab locations are in place to assure product quality.

+ Evaluates laboratory systems, processes, procedures and equipment as they relate to established regulatory and quality requirements and consistency between two lab locations.

+ Partners with internal audit team on internal quality assurance audits to evaluate laboratory systems to ensure compliance and quality.

+ Partners with Validation Department for equipment and computer qualification, process validation, and revalidation after repairs to ensure requirements are met for both lab locations.

+ Partners with Quality Systems Department to ensure proper oversight and corrective/preventive actions are executed, implemented and monitored through established quality systems for both lab locations

+ Partners with CLIA Director/Designee to monitor CLIA and other proficiency testing programs to ensure adequacy of test methods, equipment and personnel competency for both lab locations.

+ Be a member of the audit support team to prepare for and participate in FDA, CLIA, EMEA, BioLife, OSHA and other inspections.

+ Lead operational excellence initiatives on the lab floor for both lab locations for the Quality Operations Department to drive a culture of continuous improvement to achieve site operational excellence goals (including but not limited to 5S, Value Stream Mapping and Kaizen.

+ Works in conjunction with Mangers of Quality Systems, Validation, Training, Lab Services and Laboratory Operations in the implementation, monitoring, and maintenance of laboratory quality systems.

+ Interviews, hires, and supervises performance of laboratory quality assurance staff for the lab floor of 2 lab locations.

+ Ensures that proper training of laboratory quality assurance staff of the lab floor is performed and documented in 2 lab locations.

+ Other duties as assigned or necessary for proper quality oversight of lab operations

+ **For both lab locations, through subordinates, ensures daily testing and quality control records are reviewed before release of test results to donor centers to verify that:**

+ Controls and standards are within acceptable ranges,

+ All runs are valid,

+ All initially reactive samples are retested in duplicate and entered accordingly on appropriate reports,

+ All quality control parameters are within acceptable ranges.

_DIMENSIONS AND ASPECTS_

Technical/Functional (Line) Expertise

+ Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.

+ Demonstrate work history of above average performance and attendance.

+ Excellent interpersonal skills and communication skills including written, verbal and oral presentations.

+ Result oriented with ability to adapt to changing priorities.

+ Attention to detail and organizational skills with analytical and problem solving skills.

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

+ Walking, standing, observing others performing work assignments.

+ Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, leaning.

+ Ability to work in an office / production environment.

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

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.

Complexity

+ 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.

_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_

+ Bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; **and** have at least 7 years of laboratory training and/or experience, or both, in high/moderate complexity testing.

Desired:

MT certification by ASCP or equivalent certifying organization preferred

5 to 7 years’ experience in a professional or technical capacity in a laboratory, blood services, or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.

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

5-8 years management experience preferred.

Travel up to 25% may be required

BioLife Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - GA - Social Circle - Baxter Pkwy

$133,000.00 - $209,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.  The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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 - Baxter PkwyUSA - AL - Hoover

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes