Sr. Quality Risk Management Specialist

247279BR
Sr. Quality Risk Management Specialist
PURPOSE
Sr. Quality Risk Management Specialist provides leadership to the CGTDM QMS organization in the oversight of the Quality Risk Management Program. Leads or supports the management, monitoring, tracking, and reporting of quality risk assessments and mitigation/remediation actions. Supports the broader QMS organization processes (Documentation, APQR, CAPA, Quality Events, etc.) as needed.

MAJOR RESPONSIBILITIES
• Function as Quality Risk Management Program lead for CGTDM responsible for working with respective Business Process owners to define the risks of each of their respective quality systems and the overall “state” of control and/or health of that quality system.
• Ensure proactive approach to the Quality Risk Management Program to identify potential risk to quality, safety and efficacy of CGTDM products and processes.
• Provide Quality Risk Management Program support and guidance to Business Process owners, CGTDM SMEs and site personnel as needed to facilitate the completion of quality risk assessment and actions.
• Responsible for monitoring, tracking, and reporting of quality risk assessments and mitigation/remediation actions, including escalation when required following established NVS escalation process.
• Responsible for establishing and maintaining quality risk assessment tracking tool to monitor and provide transparency of CGTDM quality risk assessments and track/ensure completion of all mitigation/remediation actions.
• Review and/or approve quality risk assessments and Quality Events as Quality Compliance and QMS SME when applicable.
• Establish and maintain compliant procedures and processes for Quality Risk Management that ensure alignment with NVS Quality Manual, GOPs, and CGT QMS requirements.
• Lead or support the creation/revision of Quality Modules, GOPs, SOPs, WPs, FRMs and technical reports related to Quality Risk Management as a subject matter expert for CGTDM.
• Support CGTDM SPOC with QM/GOP implementation process, including assigning and coordinating assessments with CGTDM SMEs, tracking progress through completion, and metric reporting to ensure alignment across CGTDM and NTO/Biotechnology network (as applicable).
• Lead or support Quality Compliance and QMS projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with GMP and Novartis Quality and Data Integrity standards.
• Enter/maintain information accurately following GDocP to support life cycle management of quality risk assessments.
• Support Tier 1 and Tier 2 Quality Compliance and QMS meetings. Develop and provide meaningful CGTDM data and KPI’s for Quality Risk Management System for APQR, SQC and/or QRB.

SUPPORTIVE ACCOUNTABILITIES
• Maintain current knowledge of local and international regulatory/legislative requirements, guidance, and trends as well as Novartis Quality and Data Integrity Standards.
• Present quality risk management program as SME during self-inspections, internal/external audits and Health Authority inspections. Interact with Health Authority, partner and supplier auditors/inspectors as needed.
• Support regulatory filings as needed.
• Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements.
• Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Education: Bachelors or higher in Chemistry, Pharmacy, Microbiology, Biology or other related science required.

Languages: English: fluent in reading, speaking, and writing. Additional language(s) preferred.

Experience: 8 or more years of professional pharmaceutical experience, with 3 or more years of quality risk management, quality assurance, quality compliance/QMS, manufacturing, engineering, and/or validation preferred. 1 or more years of experience in a leadership role also preferred.
Novartis Technical Operations
NTO BTDM
USA
Morris Plains
Novartis Pharmaceuticals
Quality
Full Time
Regular