Associate Director, Quality Control

Scorpion Therapeutics; Brooklyn Park (MN); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical/dental/vision

401(k) with match

Disability and life insurance

Tuition reimbursement

Paid volunteer time off/holidays

Well-being benefits

Sick time (80 hours)

Paid vacation (120 hours)

Job summary

Scorpion Therapeutics in Brooklyn Park, MN is seeking an Associate Director, Quality Control to provide strategic and operational leadership for QC laboratory functions, including analytical chemistry, microbiology, and bioanalytical testing. You will ensure compliant testing of materials and finished drug substances and drive cGMP compliance.

You will lead the QC team, manage investigations, deviations, CAPA, and change control, and guide audits and inspections with a strong focus on data

Qualifications

• Bachelor's degree in life sciences or related field required.
• 10+ years in regulated laboratory operations with leadership experience.
• FDA/EMA/PDA and other regulatory requirements knowledge.

Responsibilities

• Lead QC laboratory operations (analytical chemistry, microbiology, bioanalytical).
• Manage teams supporting routine, in-process, release, stability, and investigations.
• 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.

Skills

People leadership

Regulatory inspections readiness

Quality management

Education

Bachelor's degree in life sciences

Master's or PhD preferred

Tools

TrackWise

SAP

Microsoft Office

Job description

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.