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Job Description

Job Title: Final Drug Product Quality Manager

Location: Thousand Oaks, CA

About the role:

You will manage the quality daily operations associated with Assembly and Final Packaging.

This is an on site role that reports to the Head of QA Validation.

How you will contribute:

• Manage Quality staff for packaging/inspection operations and material receiving/inspection. Coach, develop and provide feedback to lead individual and team performance.
• Ensure adherence to facility quality systems such as batch record review, product release, change control, exception management, and product annual reviews. Work with manufacturing management in cGMP compliance and quality systems.
• Manage investigations, CAPAs, batch record review, product release, change control, requalification and product quality review associated with Final Packaging organization.
• Manage resources to ensure product/material cycle times are met for supply chain demands. Implement lean concepts to improve cycle times within the area.
• Assure product meets requirements for product and material specifications to applicable geographies. Assure release of product/materials associated with automated device assembly processes and sterilization of medical devices, including Vaporized Hydrogen Peroxide (VHP) sterilization methods.
• Provide direction in the event of manufacturing incidents that may potentially affect quality or compliance. Approval of Product Complaint evaluations.
• Be the quality lead for visual inspection, ensuring compliance, global alignment and meeting regulatory requirements / current industry practices by demonstrating understanding of Visual Inspection and regulatory requirements. Ensure compliance with current regulatory or product license requirements and cGMPs.
• Review and approve changes within the manufacturing area including changes to process, equipment, facilities, procedures, and computerized systems.
• Support the Thousand Oaks facility during external and regulatory inspections. Work directly with the investigators on defending facility quality systems and product investigations.
• Set annual budget and manage resources to meet annual budget, and perform other duties as assigned.

What you bring to Takeda:

• Bachelor's degree in sciences or engineering.
• Minimum 7 years' experience in a quality operations position in a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Minimum 3 years of leadership, supervisory or management experience desirable.
• Experience in automated device assembly processes and sterilization of medical devices, including Vaporized Hydrogen Peroxide (VHP) sterilization methods.

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:

• The overall physical exertion of this position is sedentary work.
• May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Work more than 8 hours a day or 40 hours a workweek as required.
• Work outside regular business hours and weekends as required.

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.

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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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