Job Purpose: Implements and maintains assigned Quality Control laboratories in an effective and compliant manner. Supervises the activities and development of direct reports. Contributes to the site’s understanding and adoption of the Quality System.
• Develops and maintains applicable site SOPs, documentation and records within the Novartis Quality Management System
• Responsible for management of quality control laboratory including microbiology testing (sterility testing, bioburden, endotoxin, and microbial identification), PCR, cell culture and virus handling.
• Ensures the integrity of all Quality Control records and data, as applicable.
• Supervises the activity of direct reports.
• Ensures collaboration of own team with other functions and departments.
• Ensures effective professional development of direct reports, through combination of coaching, mentoring and effective development planning.
• Provides oversight of assigned functions to ensure that HS site operations are compliant and consistent with NVS Quality System.
• 5+ years’ relevant experience within the biopharmaceutical industry with experience in biotechnology and aseptic processing required.
• 2+ years of supervisory experience or demonstrated leadership role preferred.
• Demonstrated knowledge of GMPs and FDA requirements is required
• Quality Systems experience desirable.
• Advanced knowledge of microbiology and virology methods and testing required.
• Experience with Labware LIMS, SAP, TrackWise desired.
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...