Associate Director, Quality Control

Bachelor’s degree in life sciences, chemistry, engineering, or another related technical discipline required.

Master’s degree or Ph.D. preferred.

10 years of experience in pharmaceutical, biotechnology, biological-product, or regulated laboratory operations.

Experience leading analytical chemistry, microbiology, bioanalytical, or other multidisciplinary QC laboratory functions.

6+ years of management and people-leadership experience required; experience leading large or 24/7 laboratory organizations strongly preferred.

Experience with regulatory inspections, audit readiness, and laboratory compliance.

Experience with method transfers, laboratory systems, Deviation/CAPA, Change Control, and Quality Risk Management.

Experience with TrackWise, SAP, Microsoft Office, and related laboratory or quality systems preferred.

Knowledge of endotoxin and sterility testing preferred.

In-depth knowledge of cGMPs, Good Data and Documentation Practices, and applicable FDA, EMA, PDA, and other regulatory requirements.

Strong understanding of laboratory operations, analytical methods, microbiology, sterility assurance, and contamination control. Knowledge of data analytics, digital laboratory innovation, Lean, and Six Sigma concepts preferred.

Perform work involving moderate to high scope, complexity, and organizational impact.

Operate independently with general direction, applying policies, standards, scientific principles, and regulatory expectations.

Troubleshoot technical, operational, compliance, and quality issues and determines appropriate corrective and preventive actions.

Balance competing business, quality, compliance, staffing, and resource priorities.

Implement global QC strategies using sound scientific principles and international regulatory standards.

Identifie risks, escalates significant issues appropriately, and makes quality decisions aligned with Takeda policies and site procedures.

Build alignment and consensus with collaborators and customers across functions and organizational levels.

Other Job Requirements

Ability to work in controlled environments requiring special gowning and personal protective equipment.

May be required to work in clean rooms, confined areas, and cool or hot storage environments.

Ability to stand for extended periods and perform work in QC laboratory settings.

Requires wrist and hand motion for activities such as typing and writing.

May be required to work multiple shifts, weekends, or provide support for 24/7 laboratory operations.

Willingness to travel for meetings, training, inspections, or other business needs; approximately 5–10% travel.

Reasonable accommodations may be made to enable individuals with disabilities.

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:

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.

For information about our benefits, please click here.

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.

Job Exempt