Specialist, Quality Control Microbiology

Novartis • Durham, NC

3d • Onsite

About The Position

Manage Quality aspects of clinical programs and projects within area of responsibility. Ensure and support overall GxP conformity and Compliance with the Novartis Quality Management Systems. Identify and execute on OpEx opportunities. Build/manage stakeholder relationships and expectations Job Description Location: Durham, NC #LI-Onsite Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Major accountabilities: Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting -Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner -Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual -Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality. Contributes to an improvement of current processes and/or to an implementation of modified processes. Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate. Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments -Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation Supports Compliance review of projects and inspection readiness and management -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: In accordance with departmental objectives such as support of projects with agreed quality and delivery date -passing of internal and external inspections. Maintain sound working relationships with partners and customers -Demonstrated/recognized leader of specific GxP; early external/industry engagement -Basic financial knowledge (e.g., cost management, budget forecast, etc.) -Role Model of Novartis culture, values & behaviors for his/her department

Requirements

• Functional Breadth
• Collaborating across boundaries
• Operations Management and Execution
• Project Management
• Agility
• Audit Management
• Business Partnering
• Change Control
• Continuous Learning
• Health Authorities
• Influencing Skills
• Knowledge Of Capa
• Qa (Quality Assurance)
• Quality Management
• Quality Management Systems (Qms)
• Risk Management
• Root Cause Analysis (Rca)
• Self Awareness
• Sop (Standard Operating Procedure)
• Technological Expertise
• English

Responsibilities

• Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting
• Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner
• Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual
• Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management.
• Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality.
• Contributes to an improvement of current processes and/or to an implementation of modified processes.
• Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate.
• Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments
• Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation Supports Compliance review of projects and inspection readiness and management
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)
• support of projects with agreed quality and delivery date
• passing of internal and external inspections.
• Maintain sound working relationships with partners and customers
• Demonstrated/recognized leader of specific GxP; early external/industry engagement
• Basic financial knowledge (e.g., cost management, budget forecast, etc.)
• Role Model of Novartis culture, values & behaviors for his/her department

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees