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Job Description

Job Title: Quality Assurance Manager

Location: Thousand Oaks, CA

About the Role:

As the Quality Assurance Manager, you will manage the daily Quality operations of the Quality Shop Floor team for manufacturing operations, ensuring compliance with Takeda's quality policies, and government regulations. The team will support manufacturing staff by detecting and resolving compliance issues in real time. You and your team will provide essential quality oversight and real-time GMP support during manufacturing activities to ensure the safety and reliability of Takeda products.

You will mentor your QA team and be an important member of the site Quality Team, working with teams, including Manufacturing and product support, to ensure compliance, product safety, and internal partnerships. You and your team will communicate quality and compliance risks, while contributing to the development of plans to address these issues in real time. You will report to the Head of Quality Assurance.

How you will contribute:

• Lead Quality staff supporting drug substance and finishing manufacturing areas.
• Coach and provide feedback to lead personal and team performance.
• Oversee recruitment, training, and plan for future talent needs. Provide support for a variety of activities to ensure compliance with quality goals, goals and regulatory requirements including: oversight of floor operations and approval of batch documentation and resolving issues before batch release, review of deviations for manufacturing areas including drug substance, device assembly and packaging operations and ensure operations and products meets requirements for product specifications to applicable geographies.
• Manage resources to ensure production, material, and release cycle times meet supply chain demands.
• Implement lean concepts to improve cycle times within the area.
• Work with manufacturing management in areas of CGMP compliance and quality systems.
• Provide direction in the event of manufacturing incidents that may potentially affect quality or compliance
• Ensure compliance with current regulatory or product license requirements and CGMPs.
• Support the Thousand Oaks facility during external and regulatory inspections, directly engaging with investigators to defend quality systems and product investigation
• Partner with manufacturing teams to improve production, solve problems, improve quality, boost efficiency, reduce costs, and support new products. May also assist with complex investigations
• May be Quality lead for visual inspections processes, ensuring compliance, global alignment and meeting regulatory requirements/current industry practices.
• May be responsible for management of investigations, CAPAs, batch record review, assisting with product release, change control, requalification, and product annual review in the manufacturing area.
• May be responsible for approval of changes within the manufacturing area including changes to process, equipment, procedures, and computerized systems.
• Support new product introductions to the site.

What you bring to Takeda:

• Bachelor's degree in sciences or engineering preferred.
• Minimum 10 years' experience in a quality operations position in a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Minimum 5 years of leadership, supervisory or management experience preferred.
• Have technical skills with substantial knowledge of industry best practices, trends, and an understanding of the Biopharmaceutical business.
• Experience in microbial control strategies for pharmaceutical manufacturing, cleanroom cleaning, sanitization, material transfer methods and environmental monitoring, and investigational trouble shooting and managing projects in a global environment
• Experience in the following areas: Drug substance/drug production operations, automated device assembly processes and sterilization of medical devices including understanding of visual inspection and regulatory requirements, clean-in-place and out-of-place, steam-in-place and Vaporized Hydrogen Peroxide (VHP) cleaning, sterilization and surface decontamination methods, product, process and microbial risk assessments and general knowledge of quality risk management (QRM) and advanced knowledge in CGMP, CFR, USP and GDP, and manufacturing processes, laboratory operations and/or critical systems
• Experience in biologics production and materials/components
• Proficiency in multiple quality systems including exception management, change control, document control, product release, supplier quality with using risk management.
• Knowledge of CGMP (US, EU, Canadian, Japan) preferred including FDA aseptic processing guidance and EU Annex 1 requirements for sterile product manufacturing.
• Proficiency in problem solving using continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent.

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 be required to 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.
• Able to work more than 8 hours a day or 40 hours a workweek as required.
• Availability outside regular business hours and weekends as required.
• The overall physical exertion of this position is sedentary work.

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

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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