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Job Description

About the role:

As the QC Manager, you will plan, organize, supervisor, and monitor the daily operations, activities, and workflow for the laboratory personnel in the Quality Control (QC) lab. Implement testing standards, policies and ensure safety measures are followed. This role will manage laboratory personnel with training, development, performance, and other areas as needed. You will report into the Head of Quality Control Labs.

How you will contribute:

• Manage the lab operations of your designated area of including oversight of day-to-day priorities, scheduling and activities

• Build a team, provide training, ongoing coaching, and performance management, including annual performance reviews

• Support recruitment, development, and recognition of staff

• Responsible for alignment with Global procedures and documentation authoring (e.g. quality improvement plans, risk assessments, protocols, reports, regulatory submissions, etc.)

• Provide technical knowledge and/or support investigation teams for QC related systems, processes, procedures, and test methods

• Support investigations into atypical results and troubleshooting of assays and instrumentation

• Assist in the development, establishment and monitoring of systems that focus on key performance indicators within the QC department

• Be directly involved in and lead multiple process/product improvement projects.  These projects may be executed through Deviations/CAPA, Belt Projects (Blue Belts / Green Belts), Kaizens, or other focus groups

• Ensure on time completion of all testing, including special projects/protocols and ensure accuracy of laboratory documentation

• Assist in laboratory audit ready status efforts in understanding FDA, Takeda, and other regulatory and quality requirements.  Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance with these requirements

• Operational liaison with various customers including Manufacturing, Quality Assurance and Manufacturing Services

• Support Continuous Improvements in the QC Microbiology department; Support initiatives such as the site CI Master Plan, 5S, Visual Controls, VIPs, Lean Labs, etc

• Assure equipment maintenance and calibration, and internal audits are performed on schedule.

Minimum Requirements/Qualifications:

• Technical science degrees required (Chemistry preferred)

• Bachelor’s Degree with 7 years of related work experience OR Master’s Degree or MBA with 5 years of related work experience

• At least 2 years of leadership experience

• Experience or Certified training in DMAIC and LEAN concepts preferred.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda 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.

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U.S. Base Salary Range:

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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Job Exempt