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Job Description

Job Title: Quality Compliance Specialist II

Location: Lexington, MA

About the role:

You will be responsible for all quality improvement issues related to vendors and suppliers of materials, products and services. You will execute the global Supplier Quality and Material Management programs at the MA Bio Ops plant, and support local team members and stakeholders in the Biologics OpU on matters pertaining to supplier controls, significant concerns related to Quality System performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance.

This is a hybrid position that reports to the Manager, Supplier Quality and Auditing.

How you will contribute:

• Lead Supplier Notifications of Change (SNC) process
• Co-audit internal or external quality systems and supplier questionnaires
• Coordinate with suppliers and MA Bio Ops supply chain teams to resolve nonconforming raw material (RMNCMR) issues
• Perform Change Control SQ tasks due to technical transfers and necessary product/material specification changes
• Undertake supporting role in regulatory inspections, as needed
• Support New Supplier Request (NSR) workflows and Trackwise record updates
• Material Qualification Report reviews
• Support regulatory document requests

What you bring to Takeda:

• Bachelor's Degree in a Scientific Discipline
• 2+ Years experience leading cross functional teams in a life sciences environment
• 1+ years of experience with Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) including global cGMP regulations (US, EU, Japan, Canada) desirable
• 1+ years of experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections desirable

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

#GMSGQ #ZR1 #LI-MA1 #LI-Hybrid

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.

For Location:

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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