Associate Director, Quality Control Leadership

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

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