About the role
The QC Laboratory Operations Lead is responsible for managing core Quality Control support functions at WuXi STA's drug product manufacturing facility in Middletown, DE. This role provides leadership and oversight for Stability Program Management, Sample Lifecycle Management, Metrology and Laboratory Equipment Lifecycle Management, Inventory and Consumable Control Management, and critical laboratory electronic systems, like Empower and LIMS.
What they're looking for
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related scientific discipline required, advanced degree preferred
- Minimum 7 years of GMP pharmaceutical laboratory experience with at least 3 years in leadership or supervisory roles
- Demonstrated experience managing laboratory operations, stability programs, sample management, metrology, equipment programs, or laboratory systems
- Strong understanding of GMP regulations, data integrity principles (ALCOA+), and regulatory inspection expectations
- Experience with LIMS, CDS, stability management software, inventory systems, and computerized system compliance
- Proven ability to manage multiple priorities in a fast-paced pharmaceutical manufacturing environment
More about this role
The QC Laboratory Operations Lead is responsible for managing core Quality Control support functions at WuXi STA's drug product manufacturing facility in Middletown, DE. This role provides leadership and oversight for Stability Program Management, Sample Lifecycle Management, Metrology and Laboratory Equipment Lifecycle Management, Inventory and Consumable Control Management, and critical laboratory electronic systems, like Empower and LIMS. The position ensures laboratory operations are adequately resourced, compliant with current GMP requirements, inspection-ready, and capable of supporting manufacturing, product release, and stability commitments. The QC Laboratory Operations Lead collaborates closely with QC Analytical, QC Microbiology, Manufacturing, Quality Assurance, Validation, Engineering, and Information Technology to ensure effective laboratory operations and continuous improvement.
- Own and manage the site stability program, including study initiation, sample pulls, scheduling, storage, inventory tracking, and sample reconciliation.
- Ensure stability studies are executed in accordance with approved protocols, regulatory requirements, and client commitments.
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