QC Laboratory Operations Lead

About the role

The QC Laboratory Operations Lead manages core Quality Control support functions at WuXi STA's drug product manufacturing facility in Middletown, DE.

Responsibilities

• 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.
• Cook stability chamber utilization, monitoring, qualification activities, and capacity planning.
• Maintain stability databases and ensure accurate tracking of all stability samples throughout the study lifecycle.
• Monitor program performance and ensure timely communication of upcoming testing requirements.
• Lead laboratory sample management operations from receipt through storage, distribution throughout the testing groups, reconciliation, retention, and disposal.
• Develop and/or maintain procedures governing sample custody, chain of custody documentation, and sample traceability.
• Manage sample logistics supporting release testing, stability testing, investigations, validation activities, and client requests.
• Ensure sample inventory systems are maintained accurately and support efficient laboratory workflows.
• Identify and implement improvements to sample handling processes that enhance compliance and operational efficiency.
• Oversee the full lifecycle management of laboratory equipment, including procurement, commissioning, qualification, calibration, preventive maintenance, repair, and retirement.
• Manage equipment scheduling to ensure continuous laboratory readiness and minimize downtime.
• Partner with Validation, Engineering, and vendors to support instrument qualification and maintenance activities.
• Ensure calibration and maintenance programs are executed within established due dates.
• Monitor equipment performance metrics and drive continuous improvement initiatives.
• Monitor vendor performance metrics and implement contingency plans where necessary to ensure there is no disruption to throughput.
• Maintain equipment inventory records and ensure compliance with applicable GMP requirements.
• Establish and manage laboratory inventory programs for reagents, consumables, reference standards, columns, and critical supplies.
• Monitor inventory levels and implement forecasting processes to ensure uninterrupted laboratory operations.
• Cohort purchasing activities and maintain appropriate stock levels while minimizing waste and expired materials.
• Ensure materials are received, stored, qualified, and utilized according to approved procedures.
• Develop key performance metrics related to inventory utilization, availability, and cost management.
• Lead small team of dedicated contractors supporting consumable materials.
• Serve as business owner or system administrator for critical laboratory computerized systems, including LIMS, CDS, Electronic Laboratory Notebooks, and related GMP applications.
• Cook system access management, user administration, configuration changes, periodic reviews, and data integrity activities.
• Pear with IT, Quality Assurance, and system vendors to maintain system compliance and operational effectiveness.
• Support computer system validation activities and change control processes.
• Ensure regulatory compliance with data integrity requirements and maintain inspection readiness for all laboratory systems.
• Ensure laboratory operational processes comply with FDA, EMA, ICH, and applicable GMP regulations.
• Support investigations, deviations, CAPAs, change controls, and risk assessments associated with laboratory operations.
• Participate in internal audits, client audits, and regulatory inspections.
• Monitor compliance trends and implement preventive actions to reduce operational risk.
• Drive continuous improvement initiatives to improve efficiency, compliance, and employee engagement.
• Build, develop, and lead the Laboratory Operations team.
• Provide coaching, mentoring, training and career development opportunities for team members.
• Establish performance expectations and conduct routine performance evaluations.
• Manage staffing, resource allocation, and succession planning.
• Foster a culture focused on compliance, operational excellence, accountability, and continuous improvement.

  Requirements

  • 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.
  • Strong organizational, communication, project management, and leadership skills.

  Qualifications

  • 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.
  • Strong organizational, communication, project management, and leadership skills.

  Skills

  • Leadership
  • Project Management
  • Quality Systems
  • Data Integrity
  • Computerized System Compliance
  • Inventory Management
  • Stability Management
  • Sample Management
  • Laboratory Equipment Management
  • Compliance
  • Regulatory Inspection
  • Internal Audits
  • Client Audits
  • Continuous Improvement
  • Team Building
  • Performance Evaluation
  • Succession Planning
  • Compliance Culture
  • Operational Excellence
  • Accountability
  • Employee Engagement

  Benefits

  N/A

  Pay

  N/A

  Schedule

  N/A