TRD QA CGT Modality Head
Novartis
August 23, 2026
On-site
East Hanover, NJ
Operations
Role Purpose
Lead/manage and/or provide quality oversight in development and research functions (clinical trial processes, safety systems/procedures, product release/handovers, and projects) to ensure compliance with health authority requirements, internal standards, and patient safety, rights, and well-being. Provide risk analysis and quality expertise for critical decisions; drive a culture of quality.
Major Accountabilities
- Ensure quality and data management systems/practices are established, maintained, and effective (e.g., GCP, PV, GLP, GMP/medical device, IP, change/design control, training, complaints audits, quality certifications).
- Provide QA leadership and increase quality awareness in R&D.
- Lead and manage a global QA organization and/or global quality project team; monitor annual Quality Plan implementation.
- Ensure adherence to global/local safety and regulatory standards (GCP, GLP, GMP, PV, IP).
- Oversee proactive quality risk management (quality risk assessments, remediation, submission/inspection readiness).
- Establish/lead governance for deviation/incident management; provide regulatory guidance for quality oversight of internal monitoring and outsourced activities.
- Support inspection preparation and facilitation; participate in audits/inspections and CAPA follow-up.
- Communicate lessons learned; drive proactive, risk-based behavior.
- Report technical complaints/adverse events/special cases within 24 hours of receipt.
- Distribute marketing samples (where applicable).
Key Performance Indicators
- Up-to-date and implemented GxP Quality Management System.
- Quality oversight on global and local clinical vendor established.
Work Experience
Audit & inspection management; quality management systems/assurance; GxP; cGMP; people management; quality compliance; drug development/research; regulatory affairs; complaints management; GLP analytics; incident management; patient safety; pharmacovigilance.
Language
- English.
Compensation/Benefits (if eligible)
- Salary range: $176,400–$327,600/year; performance-based cash incentive; possible annual equity awards; comprehensive benefits and time off package.
Lead/manage and/or provide quality oversight in development and research functions (clinical trial processes, safety systems/procedures, product release/handovers, and projects) to ensure compliance with health authority requirements, internal standards, and patient safety, rights, and well-being. Provide risk analysis and quality expertise for critical decisions; drive a culture of quality.
Major Accountabilities
- Ensure quality and data management systems/practices are established, maintained, and effective (e.g., GCP, PV, GLP, GMP/medical device, IP, change/design control, training, complaints audits, quality certifications).
- Provide QA leadership and increase quality awareness in R&D.
- Lead and manage a global QA organization and/or global quality project team; monitor annual Quality Plan implementation.
- Ensure adherence to global/local safety and regulatory standards (GCP, GLP, GMP, PV, IP).
- Oversee proactive quality risk management (quality risk assessments, remediation, submission/inspection readiness).
- Establish/lead governance for deviation/incident management; provide regulatory guidance for quality oversight of internal monitoring and outsourced activities.
- Support inspection preparation and facilitation; participate in audits/inspections and CAPA follow-up.
- Communicate lessons learned; drive proactive, risk-based behavior.
- Report technical complaints/adverse events/special cases within 24 hours of receipt.
- Distribute marketing samples (where applicable).
Key Performance Indicators
- Up-to-date and implemented GxP Quality Management System.
- Quality oversight on global and local clinical vendor established.
Work Experience
Audit & inspection management; quality management systems/assurance; GxP; cGMP; people management; quality compliance; drug development/research; regulatory affairs; complaints management; GLP analytics; incident management; patient safety; pharmacovigilance.
Language
- English.
Compensation/Benefits (if eligible)
- Salary range: $176,400–$327,600/year; performance-based cash incentive; possible annual equity awards; comprehensive benefits and time off package.