Manager Quality Systems
A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement.
Think what's possible.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Job Purpose:
Develop and maintain the quality systems for Deviation and CAPA Management and Change Control. Perform technical assessment and QA oversight for deviations, CAPAs, and change controls.
To provide strategic and technical support for the US FCC site in cGMP compliance related Quality Systems matters and to ensure that all aspects regarding deviations and change controls comply with cGMP, regulatory requirements, and the Novartis VD Quality Manual requirements.
Major Accountabilities:
• Lead groups responsible for QA oversight for the Holly Springs Change Control and Deviation/CAPA Management systems. QA subject matter expert for these quality systems.
• Ensure that GMP changes related to process, materials, equipment/facilities, methods, and computerized systems comply with requirements of the Novartis VD Quality Manual and meet all relevant cGMP regulatory requirements.
• Provides technical assessment of changes in addition to ensuring the change is executed compliantly and within requirements. Reviews and approves changes for implementation and performs review/approval of changes for closure.
• Ensure high level of QA oversight of deviation investigation. Perform comprehensive QA review and approval of deviation investigation reports to ensure robustness of investigations, correct determination of root causes, and implementation of appropriate corrective and preventive actions. QA approval of major and critical deviation investigations.
• Identify and implement process/procedural improvements related to the change control and deviation/CAPA quality systems. Implement systems to improve efficiencies and robustness of systems.
• Member of the site Change Control Review Board. Participates as a site representative on the Global Change Control Review Board. Member of the site Deviation Review Board.
• Act as SME for change control and deviation/CAPA systems in divisional and health authority audits.
• Responsible for metrics and trending related to site change control and deviation/CAPA systems. Identify and implement improvements to quality systems based on trend information.
• Develop, coach, and mentor direct reports. Performance management of staff.
• Provide support for the local Product Technical Complaint (PTC) process, as necessary for PTC investigations.
• Bachelor's Degree in Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry or other related area.
• Minimum of 8 years in Quality Assurance with direct experience in root cause analysis, technical writing and prior experience in deviation management.
• Experience with electronic Change Control and Deviation/CAPA Systems required.
• Direct experience with TrackWise system desirable.
• Additional experience in technical operations and/or manufacturing in a GMP regulated environment within the pharmaceutical industry a plus.
• Sterile product manufacturing knowledge desired.
• Biopharmaceutical experience a plus.
• Experience in execution/oversight of process, equipment, facility or computerized systems validation a plus.
• Previous experience managing people desriable.
• Position may require international travel for projects.
