TRD QA CGT Modality Head

Novartis Group Companies; East Hanover (NJ); On-site; USD 176,400 - 327,600; Full time

Benefits offered by this job

Health benefits

Life and disability insurance

401(k) with company match

Generous time off

Job summary

Novartis Group of Companies in East Hanover, NJ is seeking a senior QA leader to oversee development, research, and clinical safety systems to ensure compliance with health authorities and internal standards. The role requires driving a culture of quality across global teams and managing risk-based QA activities onsite.

The position focuses on leading QA governance, inspections readiness, and CAPA processes, with responsibility for ensuring GCP, GLP, GMP, PV, IP compliance across programs and

Qualifications

• Oversee QA leadership to ensure quality compliance across research and development activities.
• Ensure adherence to GxP, GLP, GMP, PV, IP standards and health authority requirements.
• Lead global QA organization and monitor the Quality Plan implementation.
• Prepare for inspections and CAPA activities and drive risk-based quality culture.

Responsibilities

• Establish and maintain quality and data management systems and oversee QA across functions.
• Provide QA leadership to ensure quality awareness in research and development activities.
• Lead a global QA organization and monitor the annual Quality Plan.
• Ensure regulatory and safety standards compliance in GCP, GLP, GMP, PV, IP.
• Oversee risk management and readiness for inspections.
• Lead governance for deviation/incident management and CAPA activities.
• Support inspections and participate in audits and inspections follow-ups.
• Communicate lessons learned from deviations and audits to drive proactive behavior.
• Report technical complaints/adverse events related to Novartis products within 24 hours.
• Distribute marketing samples where applicable.

Skills

Audit & Inspection Management

Quality Management Systems

Quality Assurance

GxP Experience

cGMP

People Management

Quality Compliance

Drug Development

Pharmacovigilance

Patient Safety

Incident Management

GLP Analytics

Job description

Job Description Summary

Location: East Hanover, NJ.

This role will be based onsite. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.

Role Purpose

Lead/manage and/or provide quality oversight in development and research functions, including clinical trial processes, medical/clinical/preclinical safety systems and procedures, product release and handover, or projects in order to ensure compliance with health authorities requirements, internal standards and a full adherence to patients' safety, rights and well-being. Provides risk analysis and quality expertise to internal stakeholders in order to make critical decisions. Drive a culture of quality through business partnering and supporting the quality mission and strategy.

Job Description

Major Accountabilities

• Ensure establishment, maintenance and effectiveness of quality and data management systems and practices and oversee all aspects of quality, which may include GCP, PV, GLP, GMP (including medical device), IP, change and design control, training, complaints audits, quality certifications, etc.
• Proactively provide strong QA leadership to the business by ensuring considerable quality and organization awareness in research and development activities
• Lead and manage a global QA organization and/or global quality project team and contribute to and regularly monitor the implementation of the annual Quality Plan
• Ensure adherence to global and local safety and regulatory internal and health authority standards, including GCP, GLP, GMP, PV, IP
• Ensure adequate oversight of proactive quality risk management process including quality risk assessments, to ensure risks are detected and remediated, and submission/inspection readiness activities
• Establish/ lead core governance for deviation/incident management for critical or major deviations, provide regulatory guidance and drive initiatives relevant to quality oversight of internal monitoring and outsourced activities
• Support inspections preparation and facilitation and participate in audits and inspections follow -up activities including CAPA preparation
• Communicate lessons learned from deviations/incidents, audits and inspections and drive a culture of proactive, risk -based behaviour
• 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

• Quality Management System for GxP up to date and implemented
• Quality oversight on global and local clinical vendor established

Work Experience

• Audit & Inspection Management
• Quality Management Systems
• Quality Assurance
• GxP Experience
• Good Manufacturing Practices (cGMP)
• People Management
• Quality Compliance
• Drug Development
• Research
• Drug Regulatory Affairs
• Technological Expertise
• Complaints Management
• Good Laboratory Practice (GLP) Analytics
• Incident Management
• Patient Safety
• Pharmacovigilance

Languages

• English.

Novartis Compensation and Benefit Summary

The salary for this position is expected to range between $176,400 and $327,600 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. 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.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$176,400.00 - $327,600.00