Associate Director, Quality Control

USA - 3345 Takeda Manufacturing U.S.A., Inc; Brooklyn Park (MN); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda in Brooklyn Park, MN is seeking an Associate Director, Quality Control to provide strategic and operational leadership for QC laboratory functions. You will ensure compliant testing of materials and products, drive continuous improvement, and partner with Manufacturing to advance quality and safety.

You will lead teams across analytical chemistry, microbiology, and bioanalytical testing, ensure timely results, and support inspections and audits while upholding Takeda’s Quality Management

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, or related field.
• 10 years of pharma, biotech, or regulated lab operations experience.
• 6+ years in management/people leadership; large 24/7 labs preferred.
• Experience with regulatory inspections, audits, and compliance.
• Familiar with method transfers, lab systems, CAPA, Change Control and QRM.

Responsibilities

• Lead QC laboratory operations including analytical chemistry, microbiology and bioanalytical testing.
• Manage laboratory teams through subordinate leaders for routine and release testing.
• Ensure timely delivery of accurate, scientifically justified results.
• Establish compliant laboratory processes, methods, and systems.
• Ensure cGMP compliance and regulatory alignment for inspections/audits.
• Provide expertise on regulations, agency guidance, and internal policies.
• Support CAPA, Deviation, Change Control, and Quality Risk Management activities.
• Lead method transfers, laboratory expansion, and new product introductions.
• Drive continuous improvement and data analytics initiatives.

Skills

Quality leadership

QC operations

Analytical chemistry

Microbiology

Bioanalytical testing

Regulatory inspections

cGMP

TrackWise

SAP

Budget management

Education

Bachelor’s degree in life sciences/chemistry/engineering

Master’s degree preferred

Ph.D. preferred

Tools

MS Office

Job description

Job Description Title

Associate Director, Quality Control

Location: Brooklyn Park, MN (Onsite)

About the role:

As an Associate Director, Quality Control, you will provide strategic and operational leadership for QC laboratory functions, including analytical chemistry, microbiology, bioanalytical testing, laboratory systems, and laboratory excellence. You will ensure the timely, compliant, and scientifically sound testing of raw materials, intermediates, in-process samples, and finished drug substance in support of manufacturing operations and patient needs. You will drive compliance with Takeda’s Quality Management System, applicable cGMP requirements, global standards, and regulatory expectations. You will also will partner up closely with Manufacturing and other Quality functions to advance safety, quality, compliance, operational performance, employee development, customer satisfaction, digital innovation, and continuous improvement. You will be part of the site Quality Leadership Team.

How will you contribute:

• Lead QC laboratory operations, including analytical chemistry, microbiology, and bioanalytical functions.


• Manage, through subordinate leaders, laboratory teams supporting routine, in-process, release, stability, and investigative testing.


• Ensure schedule adherence and timely delivery of accurate, reliable, and scientifically justified test results.


• Establish, implement, and maintain compliant laboratory processes, procedures, methods, and systems.


• Ensure compliance with Takeda policies, cGMP requirements, and both local and international regulations.


• Serve as a QC subject-matter expert during regulatory inspections, and audits.


• Provide expertise in interpreting regulations, agency guidance, internal policies, and quality standards.


• Support and oversee Deviation, CAPA, Change Control, Audit, and Quality Risk Management activities.


• Conduct gap assessments and implement improvements to the Quality Management System.


• Provide leadership for method transfers, laboratory expansion, and new product or process introductions.


• Identify, manage, and lead continuous improvement initiatives.


• Apply data analytics, Lean, Six Sigma, DMAIC, and other improvement methodologies where appropriate.


• Establish and monitor QC performance metrics, including those reported through Quality Council.


• Develop departmental budgets and ensure responsible fiscal management.


• Plan and manage staffing, succession, training, coaching, recognition, and professional development.


• Hire, develop, motivate, and retain technical and management personnel.


• Communicate priorities, objectives, project timelines, and expectations effectively to staff and stakeholders.


• Delegate responsibilities and projects based on employee capability, judgment, and experience.


• Complete mandatory training within required timeframe.


• Perform other duties as assigned.

What you bring to Takeda:

• 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. Identify 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: Brooklyn Park, MN U.S. Base Salary Range: $154,400.00 - $242,550.00 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.

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 Brooklyn Park, MN

Worker Type Employee

Worker Sub-Type Regular Time Type

Full time

Job Exempt Yes

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.