Development Quality Assurance Manager Milano

Development Quality Assurance Manager
Milano
Lombardia, Milano

220 is the number of clinical studies in which Novartis Italy is participating which provide innovative medication and treatments for more than 1200 patients.

Do you want to contribute to innovation and ensure the best quality for our patients?

As Development QA manager you will be responsible for ensuring GCP and GPV compliance in clinical studies and other post marketing projects with local regulations and global standards.

In your role you will be supporting and working together with more than 140 employees in GDD and medical functions.

Italy is a main country for Novartis in the development area with increasing importance in number of clinical studies and patients for the organization.

**Your key responsibilities**:

Your responsibilities include, but are not limited to:

- Quality Plan and Continuous Improvement: Support and monitor implementation of the local Quality Plan (QP) deliverables related to GCP and PV areas, ensuring alignment with the applicable global QP chapters wherever possible.

Utilize lessons learned from audits, inspections, KQI reviews and day-to-day oversight of quality performance to recommend and initiate continuous improvement efforts.

- Training systems: Ensure adequate training systems are in place in assigned country(ies) for GCP, GPvP and other relevant Development activities in compliance with Novartis global and local requirements.

Assure that relevant business areas are maintaining inspection-ready documentation to support reviews of training compliance.

- Quality Issue Management: Drive Clinical/PV QA investigation activities at the country level as appropriate and ensure implementation of robust CAPA plans where applicable.

Take accountability for escalation of GCP/GPvP process non-compliance as needed.

- Risk Identification and Management: 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.

Ensure adequate and timely escalation of issues to relevant functions as needed.

- Inspection Management and Support: Provide leadership and/or support as needed for GCP and GPvP HA inspections of activities in assigned country(ies).

Assure support prior to, during and post inspection for the country organization, investigational sites and/or external service providers, as applicable, in collaboration with the assigned inspection lead.

Ensure that responses to local Health Authorities are submitted on-time, commitments are agreed internally and can be met and relevant CAPAs have been completed/closed according to agreed timelines.

- CAPA management: Act as local approver for the documentation and management of local CAPAs to support appropriate review and closure of each corrective and preventive action.

Assure local line functions take appropriate ownership of duties as required by the CAPA processes.

- ESP/Supplier Management: Responsible for the execution of QA activities required for the qualification/requalification of ESPs supporting activities with a clinical/medical or PV component (including POPs).

Ensure the ESP selection, PV / QA agreements and oversight processes are properly followed at the CO for ESPs supporting Development activities with a clinical/medical or PV component (including POPs).

- Data integrity: Ensure that there is a process in place to maintain local quality and compliance with requirements for digital governance platforms and computerized systems with GCP and/or GPvP impact.

- Governance/Communication: Lead/co-lead local quality review board meetings (ex: Quality committee), 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 interface with internal/external stakeholders 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).

Coordinate and analyze clinical/medical and PV section of the AQMR.

Ensure business continuity plan is maintained and resulting measures are implemented in GCP and GPvP areas

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. _

**Minimum requirements

**What you'll bring to the role**:

- Degree in Life Sciences or related fields

- English fluent in speaking and writing

- Tipically more than 5 years' experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs,