Associate Director, Quality Control

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Job Description

Title: Associate Director, Quality Control

Location: Brooklyn Park, MN (Onsite)

• •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

• •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.

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