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Job Description

About the role:

As the Head of Quality Assurance you will lead quality oversight to ensure that all products meet applicable regulatory and Takeda quality standards across global markets. You will oversee critical quality systems including batch record review, product release, change control, deviation management, and annual product reviews, while driving compliance with cGMP and regulatory requirements. You will contribute in global and site-level strategic initiatives, supports regulatory inspections, and provides direction during quality-impacting incidents. Additionally, this position is accountable for resource and budget management, talent development, and succession planning to support long-term organizational success. You will report into the Site Quality Head.

How you will contribute:

• Assure adequate Quality oversight that meets product requirements to applicable geographies
• Ensure adherence to facility quality systems such as batch record review, product release, change control, deviation management, and product annual reviews
• Manage resources, to ensure production and product release cycle times are met for supply chain demands
• Participate on Global Core teams, site strategic projects
• Identify and assess quality risks in activities and ensure conformance to Takeda quality policies, and government regulations
• Support Quality Assurance Programs to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Site goals
• Lead the product disposition at the site for all product, including deviation quality review and disposition of product
• Provide support for several activities to ensure compliance with quality objectives and regulatory requirements
• Manage resources to ensure production and release cycle times are met for supply chain demands
• Support new product introductions to the site
• Technical skills and substantial knowledge of industry best practices and trends
• Set annual budget and manage resources to meet annual budget
• Implement lean concepts to improve cycle times within the area
• Work with manufacturing management in cGMP compliance and quality systems
• Provide direction in the event of manufacturing incidents that may potentially affect quality or compliance
• Responsible for management of investigations, CAPAs, batch record review, assisting with product release, change control, requalification, and product annual review in the manufacturing area
• Work with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, generate cost savings, and provide new product support
• Responsible for approval of changes within the manufacturing area including changes to process, equipment, procedures, and computerized systems
• Ensure compliance with current regulatory or product license requirements and cGMPs
• Support the Thousand Oaks facility during external and regulatory inspections
• Work directly with the investigators on defending facility quality systems and product investigations
• Hire and retain great talent; develop and provide challenging work for team members; support the career development of their employees both within their current position as well in situations where employees move on to different roles within the Takeda organization; manage performance and differentiate compensation and development; plan for future talent needs; improve performance

Minimum Requirements/Qualifications:

• Bachelor's degree in related field
• Minimum 10 years' experience in a manufacturing or quality operations function in a biotechnology, biologics, or pharmaceutical manufacturing facility
• Minimum 5 years previous leadership, supervisory or management experience 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.

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:

USA - CA - Thousand Oaks - Rancho Conejo

U.S. Base Salary Range:

$153,600.00 - $241,340.00

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 - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes