Associate Director, Quality Control
Takeda
August 21, 2026
On-site
Brooklyn Park, MN
$154,400 - $242,550 USD yearly
Operations
Title: Associate Director, Quality Control (Onsite) — Brooklyn Park, MN
About the role
As an Associate Director, Quality Control, provide strategic and operational leadership for QC laboratory functions (analytical chemistry, microbiology, bioanalytical testing, laboratory systems, and laboratory excellence). Ensure timely, compliant, scientifically sound testing of raw materials, intermediates, in-process samples, and finished drug substance, and drive compliance with Takeda’s Quality Management System and applicable cGMP/global regulatory expectations.
How will you contribute
- Lead QC laboratory operations (analytical chemistry, microbiology, bioanalytical).
- Manage teams supporting routine, in-process, release, stability, and investigative testing.
- Establish/maintain compliant laboratory processes, procedures, methods, and systems.
- Serve as QC subject-matter expert for regulatory inspections and audits.
- Oversee Deviation, CAPA, Change Control, Audit, and Quality Risk Management; perform gap assessments.
- Lead method transfers, lab expansion, and new product/process introductions.
- Drive continuous improvement using data analytics, Lean, Six Sigma, DMAIC.
- Set/track QC performance metrics; manage budgets and staffing/training; delegate and communicate priorities.
What you bring to Takeda
- Bachelor’s degree in life sciences, chemistry, engineering, or related technical discipline (required); Master’s/Ph.D. preferred.
- 10+ years in regulated laboratory operations; experience leading multidisciplinary QC functions.
- 6+ years management/people leadership (24/7 org experience strongly preferred).
- Regulatory inspection/audit readiness; Deviation/CAPA, Change Control, Quality Risk Management.
- Preferred: TrackWise, SAP, Microsoft Office; knowledge of endotoxin and sterility testing.
- Strong cGMP and Good Data/Documentation Practices; FDA/EMA/PDA and other regulatory requirements.
Other job requirements
- Work in controlled environments (gowning/PPE); possible clean rooms, multiple shifts/weekends; 5–10% travel.
Benefits (explicitly listed)
- Medical/dental/vision; 401(k) with match; disability and life insurance; tuition reimbursement; paid volunteer time off/holidays; well-being benefits; up to 80 hours sick time; up to 120 hours paid vacation for new hires.
Application
- Apply via the “Apply” button.
About the role
As an Associate Director, Quality Control, provide strategic and operational leadership for QC laboratory functions (analytical chemistry, microbiology, bioanalytical testing, laboratory systems, and laboratory excellence). Ensure timely, compliant, scientifically sound testing of raw materials, intermediates, in-process samples, and finished drug substance, and drive compliance with Takeda’s Quality Management System and applicable cGMP/global regulatory expectations.
How will you contribute
- Lead QC laboratory operations (analytical chemistry, microbiology, bioanalytical).
- Manage teams supporting routine, in-process, release, stability, and investigative testing.
- Establish/maintain compliant laboratory processes, procedures, methods, and systems.
- Serve as QC subject-matter expert for regulatory inspections and audits.
- Oversee Deviation, CAPA, Change Control, Audit, and Quality Risk Management; perform gap assessments.
- Lead method transfers, lab expansion, and new product/process introductions.
- Drive continuous improvement using data analytics, Lean, Six Sigma, DMAIC.
- Set/track QC performance metrics; manage budgets and staffing/training; delegate and communicate priorities.
What you bring to Takeda
- Bachelor’s degree in life sciences, chemistry, engineering, or related technical discipline (required); Master’s/Ph.D. preferred.
- 10+ years in regulated laboratory operations; experience leading multidisciplinary QC functions.
- 6+ years management/people leadership (24/7 org experience strongly preferred).
- Regulatory inspection/audit readiness; Deviation/CAPA, Change Control, Quality Risk Management.
- Preferred: TrackWise, SAP, Microsoft Office; knowledge of endotoxin and sterility testing.
- Strong cGMP and Good Data/Documentation Practices; FDA/EMA/PDA and other regulatory requirements.
Other job requirements
- Work in controlled environments (gowning/PPE); possible clean rooms, multiple shifts/weekends; 5–10% travel.
Benefits (explicitly listed)
- Medical/dental/vision; 401(k) with match; disability and life insurance; tuition reimbursement; paid volunteer time off/holidays; well-being benefits; up to 80 hours sick time; up to 120 hours paid vacation for new hires.
Application
- Apply via the “Apply” button.