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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 geographiesEnsure adherence to facility quality systems such as batch record review, product release, change control, deviation management, and product annual reviewsManage resources, to ensure production and product release cycle times are met for supply chain demandsParticipate on Global Core teams, site strategic projectsIdentify and assess quality risks in activities and ensure conformance to Takeda quality policies, and government regulationsSupport Quality Assurance Programs to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Site goalsLead the product disposition at the site for all product, including deviation quality review and disposition of productProvide support for several activities to ensure compliance with quality objectives and regulatory requirementsManage resources to ensure production and release cycle times are met for supply chain demandsSupport new product introductions to the siteTechnical skills and substantial knowledge of industry best practices and trendsSet annual budget and manage resources to meet annual budgetImplement lean concepts to improve cycle times within the areaWork with manufacturing management in cGMP compliance and quality systemsProvide direction in the event of manufacturing incidents that may potentially affect quality or complianceResponsible for management of investigations, CAPAs, batch record review, assisting with product release, change control, requalification, and product annual review in the manufacturing areaWork with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, generate cost savings, and provide new product supportResponsible for approval of changes within the manufacturing area including changes to process, equipment, procedures, and computerized systemsEnsure compliance with current regulatory or product license requirements and cGMPsSupport the Thousand Oaks facility during external and regulatory inspectionsWork directly with the investigators on defending facility quality systems and product investigationsHire 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 performanceMinimum Requirements/Qualifications:Bachelor's degree in related fieldMinimum 10 years' experience in a manufacturing or quality operations function in a biotechnology, biologics, or pharmaceutical manufacturing facilityMinimum 5 years previous leadership, supervisory or management experience requiredMore 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

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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.

LocationsUSA - CA - Thousand Oaks - Rancho Conejo

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes