Novartis · 3 weeks ago
Specialist, Quality Control Microbiology
Durham, NC
Full-time
Onsite
Mid Level
$77K/yr - $143K/yrNovartis is a leading pharmaceutical company dedicated to improving patient outcomes. The Specialist, Quality Control Microbiology will manage quality aspects of clinical programs, ensuring compliance with GxP and Novartis Quality Management Systems while building stakeholder relationships.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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)
Qualification
Required
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
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), including 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)
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
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
Benefits
Health, life and disability benefits
A 401(k) with company contribution and match
A variety of other benefits
A generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
Founded in 1996
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
Pharma Letter
2026-01-18
MedCity News
2026-01-17
Company data provided by crunchbase