TRD QA CGT Modality Head

Location

East Hanover, NJ, US. The role is onsite. Novartis does not offer relocation support. Please only apply if the location is accessible.

Lead, manage, and 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 to ensure compliance with health authorities requirements, internal standards, and a full adherence to patient safety, rights, and well-being. Provide risk analysis and quality expertise to internal stakeholders to support critical decisions and drive a culture of quality through business partnering and support of the quality mission and strategy.

• 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 organizational awareness in research and development activities.
• Lead and manage a global QA organization and/or global quality project team, contributing to and regularly monitoring 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, and IP.
• Ensure adequate oversight of proactive quality risk management processes, including quality risk assessments, to detect and remediate risks and support submission/inspection readiness activities.
• Establish or 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 inspection preparation and facilitation, and participate in audits and inspections follow‑up activities, including CAPA preparation.
• Communicate lessons learned from deviations/incidents, audits, and inspections to drive a culture of proactive, risk‑based behavior.
• Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
• Distribute marketing samples (where applicable).

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

• 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

English

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 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.