Director Quality Engineer Fda Jobs in Minnesota (NOW HIRING)

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Job DescriptionTitle: Associate Director, Quality ControlLocation: 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.

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.

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.

LocationsBrooklyn Park, MNWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Job Exempt

Yes