TRD QA Team Lead, CMC

Role Summary

The TRD QA Team Lead CMC is responsible for overseeing the product quality group and ensuring compliance for products in the portfolio from early development to late phase clinical. Drive the oversight of quality management systems and initiatives within the global, regional, and country organization, ensuring compliance with applicable health authority regulatory requirements (e.g., GCP, GLP, GMP, PV, IP) and Novartis procedures and quality standards. Role model good quality behaviors while promoting a culture of quality to positively impact non-quality stakeholders. Develop, drive and/or support Quality plan initiatives in order to achieve organizational strategy, mission and vision. Location: East Hanover NJ, Hybrid

Responsibilities

• Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP-relevant process.
• Lead and manage a QA product quality team and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met
• Translate functional QA strategy into applicable operational/compliance activities and support a risk-based implementation and execution of processes.
• Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement, including review of procedural updates, training, process improvement, effectiveness checks, etc.
• Work with team for escalations, risk and issue management to support product manufacturing testing and supply at NVS sites and at third parties.
• Support quality oversight/management of external service providers supporting activities and drive facilitation and follow-up of audits and inspections, and ensure development, implementation and completion of appropriate corrective and preventive measures for findings
• Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis and corrective actions implementation.
• Contribute towards lessons learned based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics and support a culture of proactive, risk-based behavior
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Qualifications

• Bachelor‚Äôs degree required; Master‚Äôs degree preferred.
• Minimum of 10 years‚Äô pharma quality or operations that includes at least 3 years‚Äô experience in people management
• Fundamental, broad understanding and knowledge of quality standards and policies in Drug Substance and Drug Product manufacturing and control within CGT area.
• Experience with Health Authority Inspections (FDA in particular), and knowledge of RegCMC requirements for Health Authority submissions (INDs/IMPDs).
• Broad experience in technical drug development in CGT as well as in Quality Assurance and/or Quality Control departments.
• Experience in Technical Operations CGT or equivalent experience from external company is preferred.
• Proven track record in successfully leading interdisciplinary teams, e.g. working on technical or methodological projects, in TRD or equivalent experience from external company or other line function.
• Ability to influence people, negotiate and communicate.

Skills

• QA leadership and team management
• Regulatory compliance and inspection readiness
• Quality systems and risk-based quality management
• Investigations, root cause analysis, corrective actions
• Cross-functional collaboration and stakeholder management

Education

• Bachelor‚Äôs degree; Master‚Äôs degree preferred

Additional Requirements

• Travel requirements not specified
• Physical demands not specified