QC Laboratory Operations Lead: Stability & Systems

WuXi AppTec; Town of Middletown (NY); On-site; USD 110,000 - 160,000; Full time

Job summary

WuXi AppTec in Middletown, DE seeks a QC Laboratory Operations Lead to oversee Stability Program Management, Sample Lifecycle, Metrology and Equipment Lifecycle, Inventory and Laboratory Electronic Systems. This role ensures GMP compliance, resource readiness, and inspection readiness to support manufacturing, product release, and stability commitments.

The candidate will collaborate with QC Analytical, QC Microbiology, Manufacturing, QA, Validation, Engineering, and IT to drive continuous

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related field
• Minimum 7 years GMP pharma lab experience with at least 3 years in leadership
• Experience managing lab operations, stability programs, sample management, metrology, equipment programs, or lab systems
• Strong understanding of GMP, data integrity (ALCOA+), and regulatory inspection expectations
• Experience with LIMS, CDS, stability management software, and computerized system compliance

Responsibilities

• Lead Stability Program Management to ensure studies follow approved protocols and client commitments
• Oversee Sample Lifecycle Management from receipt to disposal with traceability
• Manage Metrology and Equipment Lifecycle, including calibration and maintenance
• Administer Inventory and Consumable Management with forecasting and waste minimization
• Oversee Laboratory Electronic Systems (LIMS, CDS, ELN) and ensure data integrity and compliance
• Drive Compliance and Quality Systems including audits, CAPAs, and change controls
• Provide People Management and leadership to the Laboratory Operations team

Skills

Leadership

GMP knowledge

Data integrity

Project management

Regulatory knowledge

Education

Bachelor's degree in Chemistry/Biology/Pharmaceutical Sciences/Engineering or related scientific discipline

Advanced degree preferred

Tools

LIMS

CDS

Stability software

Job description

WuXi AppTec in Middletown, DE seeks a QC Laboratory Operations Lead to oversee Stability Program Management, Sample Lifecycle, Metrology and Equipment Lifecycle, Inventory and Laboratory Electronic Systems. This role ensures GMP compliance, resource readiness, and inspection readiness to support manufacturing, product release, and stability commitments.

The candidate will collaborate with QC Analytical, QC Microbiology, Manufacturing, QA, Validation, Engineering, and IT to drive continuous