Lead, Development Quality Assurance

1 week ago

Montréal, Canada Novartis Full time

+220 studies and 2,300 sites across multiple therapeutic areas. This is the exposure and scale our Global Development Quality. We assure quality oversight for activities undertaken in all Novartis entities and maintain the highest standards for Quality and regulatory compliance to deliver novel therapies to patients in compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines. The Lead, Development Country Quality Assurance is responsible for leading complex investigation, major health authority inspections and novel projects (e.g. developing quality risk management strategies in novel situations) for assuring the quality and compliance of Global Drug Development (GDD), Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs
- Your responsibilities include, but are not limited to:
- Drive Clinical/Pharmacovigilance QA investigation activities for Quality Issue/Incident Management at the country level as appropriate and ensure implementation of robust Corrective Action and Preventative Action (CAPA) plans where applicable. Take accountability for escalation of GCP/GPvP process non-compliance as needed.
- Support a culture of proactive, risk-based behavior. Monitor local Quality System, processes, and Key Quality Indicators (KQIs) to proactively identify potential quality risk. Collaborate with business partners to ensure that risks are reviewed for root cause, impact, and recurrence and assure that relevant line function owners put in place mitigation plans to address any compliance gaps and implement strategic process improvement, including review of procedural updates, training, and efficiency checks, etc.
- Provide leadership and/or support for Inspection Management as needed for GCP and GPvP HA inspections of activities. Assure support prior to (e.g., inspection readiness activities, including participation in regulatory inspection preparation, etc.), during and post inspection for the country organization, investigational sites and/or external service providers, as applicable, in collaboration with the assigned inspection lead.
- Partner with local and global Development teams and other internal collaborators in audit execution, and follow-up of Audits on clinical development and PV activities (including external service providers who support these activities). Collaborate with the business, and auditees as appropriate to resolve root cause for identified audit and verify robust and balanced corrective and preventive actions (CAPAs) are implemented. Act as local approver for the documentation and management of local CAPAs to support appropriate review and closure of each corrective and preventive action.
- Lead/co-lead local quality operations meetings and ensure any identified trends/risks related to PV or GCP are communicated and addressed in a timely manner. Ensure a process is in place to update local functions on the possible impact of changes to local and/or global requirements and regulations. Ensure there is an appropriate collaboration with internal/external partners for any GCP/PV related activity (e.g., local Health Authority, clinical and PV related changes/initiatives). Partner with local country quality team to ensure the analysis, assessment, and resolution of issues with common interfaces (including CAPAs).

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Minimum requirements**
- What you’ll bring to the role:
- Degree in life sciences or related field with 7+ years of experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance or a directly related area. A minimum of 3 years of experience in clinical development preferred
- Experience in leading projects
- Coaches and assists Associates in understanding new regulatory requirements and further developing their regulatory skills
- Demonstrated ability to work effectively in a multi-national, matrix organization
- Experience managing improvement projects
- Fluent in English and French

You’ll receive:
- Why consider Novartis?
- 769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
- We believe the answers are found when curious, courageous, and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
- Imagine what you could do at N

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