General Summary:
The Associate Director, GxP Operations Support Lab Systems will support laboratory information management systems (LIMS) by maintaining implemented features and delivering new functionality. Serves as Business Owner for LabVantage LIMS across all modalities and supervises a team.
Key Duties and Responsibilities:
- Lead LIMS implementation, optimization, and master data management
- Support digital strategies for real-time execution, electronic workflow orchestration, automated data collection, and equipment/system integration, including analytics and reporting
- Oversee technical review of analytical and manufacturing data and documentation
- Own deviation, CAPA, Effectiveness Check (EC), and Change Control (CC) records in eQMS
- Improve LIMS documentation, procedures, processes, and training
- Conduct and supervise LIMS training
- Develop and monitor LIMS-related KPIs
- Mentor, motivate, and evaluate team performance; set objectives aligned with company goals
Knowledge and Skills:
- 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
Education and Experience:
- Bachelorβs degree (or equivalent combination) in pharmaceutical/biotech manufacturing or quality control
- Minimum 8 yearsβ GMP pharmaceutical/biopharmaceutical industry experience
- Proven LIMS implementation/management experience, particularly LabVantage
- Direct oversight/management of personnel
Compensation:
- $161,500 - $242,300 base pay range; eligible for annual bonus and annual equity awards (overtime may apply where required).