About the role

This position holds ultimate responsibility for the overall Quality Assurance of Site Teardown and Fractionation Operations at Takeda’s Los Angeles Manufacturing Facility. The role is essential in ensuring that all quality-related activities meet regulatory standards and uphold Takeda’s commitment to excellence.

The incumbent will work in close partnership with Manufacturing and Engineering Business Unit Leaders to ensure the timely implementation and ongoing maintenance of prevention-based Quality Systems. These systems include exception management, CAPA, Change Control, and Quality on the Shop Floor, all of which are critical to maintaining compliance and driving operational efficiency.

Beyond quality oversight, the role contributes to broader strategic goals by supporting initiatives that enhance safety, employee development, customer satisfaction, continuous improvement, digital transformation, and financial performance. These efforts are aligned with the Plant Strategic Plan and reflect Takeda’s dedication to innovation and operational excellence.

The successful candidate will also be expected to champion Takeda’s Quality Culture by simplifying processes, taking pride in doing things right, fostering a speak-up culture, and demonstrating ownership and commitment to quality in every aspect of their work.

How you will contribute

• Lead multiple sections or departments within the Quality organization, ensuring product quality outcomes

• Collaborate closely with Manufacturing and Engineering teams to support Quality decisions on the shop floor, ensuring compliance with standards and procedures

• Implement and maintain Quality Systems procedures across departments, driving consistent compliance

• Ensure regulatory conformance across multiple operational areas

• Identify and resolve compliance gaps and risks proactively

• Manage or participate in quality assessments of internal operations and suppliers to evaluate compliance and risk

• Analyze trends and lead initiatives to eliminate recurring quality issues

• Engage regularly with subordinate supervisors, functional peers, and senior group managers

• Represent the company during regulatory inspections and customer audits, showcasing product and process integrity

• Lead continuous improvement and digital transformation projects to enhance quality, reliability, and cost efficiency

• Develop and manage departmental budgets, ensuring financial discipline

• Oversee coaching, training, development, succession planning, and retention strategies for team members

• May serve on the site’s Operations Leadership Team, as assigned

• Support the development and execution of the Site Strategy

What you bring to Takeda

Education & Experience

• Bachelor’s degree in science, engineering, or a related technical field (preferred: chemistry or biological sciences)

• 8+ years of relevant experience, including 3+ years in a management role with direct reports

• Deep knowledge of FDA, EMA, CFDA, and PDA regulations, including Good Data and Documentation Practices (GDDP) and current Good Manufacturing Practices (cGMP)

• Strong understanding of manufacturing operations, procedures, specifications, and regulatory standards

• Proven analytical and problem-solving skills using DMAIC and Lean methodologies

• Excellent verbal and written communication abilities

• High attention to detail and commitment to quality

• Ability to thrive in dynamic, fast-paced environments with multifunctional and global teams

• Strong interpersonal, influencing, and negotiation skills

• Confident presenter to senior leadership and external stakeholders

• Experience managing and supervising teams effectively

• Prior success interfacing with regulators and leading regulatory audits

• Yellow Belt or Green Belt training/certification (preferred)

• Results-driven mindset with a focus on continuous improvement and process simplification, including digital innovation

• Strategic execution capability to drive department and site-level initiatives

Additional Requirements

• Ability to lift, push, pull, and carry up to 10 lbs

• Comfortable working in cGMP-controlled environments with specialized gowning and protective gear

• Willingness to work in cold, wet, confined, or temperature-variable conditions

• Flexibility to work multiple shifts, including weekends

About our Los Angeles Facility:

At our Los Angeles manufacturing site, we’re united by a powerful purpose: producing life-changing plasma-derived therapies for individuals living with rare, chronic, and genetic conditions such as immunodeficiencies. With over 70 years of innovation and leadership, our facility is a cornerstone of excellence in the industry.

In 2018, our commitment to innovation and operational excellence was recognized by the International Society for Pharmaceutical Engineering (ISPE), which honored us with two Facility of the Year Awards (FOYA):

• Category Winner for Facility Integration and Overall Winner for our Los Angeles Master Plan (LAMP) project
• Category Winner for Operational Excellence for our Los Angeles QC Lab project

These accolades reflect our dedication to continuous improvement and cutting-edge facility design. Here, you’ll join a team that’s always looking ahead—finding smarter, more efficient ways to make a meaningful impact every day.

For more information, please visit:  Takeda's Manufacturing Site in Los Angeles

Where You Will Be

This role is based in a hybrid working environment, with the primary office location in Lexington or Cambridge, MA. As part of a global organization, you’ll collaborate regularly with colleagues across U.S. Eastern and Central European time zones. Flexibility, strong communication, and a collaborative mindset will be key to your success in this distributed and dynamic team setting.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

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 posting excludes Colorado applicants.

Empowering our people to shine:

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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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-termincentives. 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.