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Job Description

About the role:

Join Takeda as the Site Quality Head for our Thousand Oaks, CA Biologics Manufacturing facility where you will direct the Quality Operations organization to ensure product safety and efficacy. You will ensure compliance to applicable local, state, federal and international regulations, good manufacturing practices, good laboratory practices, and internal standards for materials, manufacturing and/or distributed finished products, packaging and labeling. You will also lead the development of all quality systems. As part of the, Biologics Operating Unit Quality team you will report to the Global Head of Quality for the OpU and work with the Thousand Oaks Site Leadership Team.

How you will contribute:

• Has direct line responsibility over the quality management function. Ensure that the Quality team is adequately staffed, that training programs are in-place and that the performance review/career development program is implemented.

• Ensure that appropriate design control procedures are in-place to ensure product safety/efficacy and compliance with applicable regulations.

• Ensure that applicable regulations are met in the manufacture and testing of product through the issuance of specifications and the development of Quality Systems.

• Work with other departments, defines, implements, and supervise the programs aimed at assessing internal and external customer requirements and satisfaction. Manage facility level corrective action response to customer dissatisfaction.

• Ensure site has appropriate programs in place to maintain an inspection ready state.

• Ensure that all operations comply with regulatory requirements; together with the OpU handles the relationships with the FDA and other regulatory agencies for inspections and their follow-ups. Ensure that manufacturing and QA procedures correspond to the contents of registration files and regulatory submissions.

• Provide technical leadership and assistance in Quality matters to suppliers manufacturing components and products.

• Provide technical assistance/leadership to other Takeda plants manufacturing components or intermediates for use in products or finished goods requirements (in cooperation with the divisions having direct line supervision over those plants.

• Lead the manufacturing Quality organizations in implementing continuous improvement activities.

• Provide leadership as a site SLT member.

• Have direct responsibility for Quality Assurance functions including product releases, inspection activities, Exception Management, Change Control, and documentation control.

• Have direct responsibility for Quality Control departments including Microbiology and Analytical Chemistry Laboratories. Direct oversight for assay validation activities and quality operations project support.

Minimum Requirements/Qualifications:

• Knowledge of cGMP manufacturing and local and global GMP regulations.

• Bachelor's degree in a scientific discipline; preferred advanced degree in a scientific discipline, business administration or certification as a quality engineer. Appropriate scientific disciplines include Pharmacy, Chemistry, Biology, Microbiology, and Engineering.

• Minimum of 10-12 years of management experience in quality and manufacturing of biologics, medical devices or pharmaceuticals.

• Understand quality assurance, quality management and quality risk management.

• Experienced managing Health Authority GMP inspections.

• Understand quality control including assay method development and assay method transfer and microbiological testing.

• Have knowledge of cGMPs for sterile manufacturing, aseptic processing including biologics and small volume parenteral or combination products.

• Work with multifunctional, global teams.

• Prior experience managing staff and budget accountability.

Important Considerations:

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. You 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.

• Need to remove all make-up, jewelry, contact lenses, nail polish 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.

• 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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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.

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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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