Location: Hybrid - Warsaw, Poland.
Other locations possible: Spain, Slovenia, Turkey.
We are looking for a Global leader of leaders responsible for the success of a Quality subfunction at the global level.
About the role:
In this global role you will be responsible for ensuring Quality oversight within a respective Novartis Technical Operations Platform or across Contract Manufacturing Organizations (CMO) and External Supply Organizations (ESO) supporting Novartis Technical Operations.
The Gl Platform Quality Head SM& LMM will be accountable for the Quality organizations for the area of responsibility in terms of budget, HC and reporting lines.This role is a permanent member of the NTO Quality Leadership Team (TQLT) and the respective Platform Leadership Team.
Key responsibilities:
• Ensure implementation and maintenance of quality systems, policies and procedures within the respective Platform or with external suppliers as well as ensure oversight and control of external suppliers related to Active Pharmaceutical Ingredient, excipients and packaging materials and a timely escalation and effective communication in order to raise quality issues to the appropriate levels of management.
• Assure sites implement a coherent Quality governance structure, including a site quality review board, a defined escalation process and quality planning.
• Ensure readiness for regulatory inspections and assure sites / regions implement a coherent Quality governance structure, including a site quality review board, a defined escalation process and quality planning.
• Improve metrics and KPI analysis to drive quality performance and drive best practice sharing across the network as well as support the implementation of new technologies and innovation including global solutions and new analytical technologies to support the NTO strategy.
• Assure sites / suppliers are improving their product performance understanding through knowledge management and continuous improvement (e.g. APR/PQR system and process capability) and drive improvement of quality standards through implementation of new Quality Modules, site quality risk assessments, regulatory compliance and quality system reviews.
• Main point of contact for the wider Novartis network for queries relating to Platform Quality and ensure that the Quality culture at the sites is implemented (through the Regional and Site Quality Heads) as well as lead the Quality section of the Platform monthly management meeting.
• Support, advice and guidance to Platform Site Quality Heads and Suppliers directly or through the Regional Heads in relation to GMP and regulatory matters and in issue resolution and escalate significant cGMP or regulatory issues to the Global Head NTO Quality and represent the Platform at the NTO Quality Leadership Council (TQLC) and follow up with Platform sites to assure the timely closure of corrective actions resulting from health authority inspections and corporate audits.
• Develop annual Site Quality Plans in cooperation with Network Sites based on inputs from Novartis and NTO Quality Plans and support product launches and PAI readiness at the Network sites.
• Budget and HC responsibility for all the sites in the platform and assure sites are developing the people in their Quality organization.