Associate Director, GxP Operations Support Lab Systems

General Summary

The Associate Director, GxP Operations Support Lab Systems will support laboratory information management systems (LIMS) through ongoing maintenance of implemented features and implementation of new functionality. Serve as Business Owner for the Lab Vantage LIMS across all modalities. Supervise a team both directly and indirectly.

• Lead implementation, optimization, and master data management of LIMS
• Support digital strategies enabling real-time execution, electronic workflow orchestration, automated data collection, equipment/system integration, analytics, and reporting
• Oversee technical review of analytical and manufacturing data and documentation
• Manage and own deviation, CAPA, Effectiveness Check (EC), and Change Control (CC) records in the electronic Quality Management System (eQMS)
• Facilitate improvements to LIMS documentation, procedures, processes, and training
• Conduct and supervise LIMS training
• Develop and monitor Key Process Indicators (KPIs) related to the LIMS system
• Mentor, motivate, and evaluate team performance; establish performance objectives aligned with company goals

• Proficiency with Microsoft Office Suite
• Strong organizational skills; ability to balance changing priorities
• Effective verbal and written communication
• Detail-oriented; accuracy and timeliness
• Ability to learn and adapt to new computer-based systems

• Bachelor’s degree or equivalent combination in a pharmaceutical/biotechnology manufacturing or quality control environment
• Minimum 8 years of experience in a GMP pharmaceutical/biopharmaceutical industry
• Proven experience implementing and managing LIMS, particularly Lab Vantage
• Direct oversight or management of personnel

• Pay Range: $161,500 - $242,300
• Eligible for an annual bonus and annual equity awards
• Medical, dental, and vision; paid time off; educational assistance (including student loan repayment); commuting subsidy; matching charitable donations; 401(k)

On-Site; five days per week on-site with ad hoc flexibility.