Head Commercial Quality, UK & Ireland

Job Description Summary

Join us as a Founder of our ‘new’ Sandoz!

 

Job Description

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. 

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

The purpose of the role:

•    Build and lead the Sandoz Country Quality Organisation, UK & Ireland and drive the Quality agenda within the Country organisation in line with Global, Regional and Country needs. 
•    Direct and lead the Country Quality organisation to ensure quality governance and enable development of effective quality values, standards and culture. Ensure compliance to all regulatory standards and that all quality relevant processes are compliant and that non-compliance is appropriately addressed via corrective & preventive actions (CAPA) and/or escalation of issues. 
•    Provide strategic and proactive QA leadership to drive and implement high performance team for 
•    quality systems and all commercial product related activities in Sandoz UK &Ireland in close collaboration with local business partners and other key stakeholders.
•    Lead the optimisation of quality processes in the Country and effectively collaborate with global internal partners to find successful solutions within the quality framework that consistently fulfil the needs of the patient and external stakeholders.
•    Prevent significant quality issues or regulatory non-compliance which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the business as well as the reputation.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Build, lead, and retain a team of high-performing quality professionals, mentor and coach individuals on the team to develop and retain quality leaders as well as build a culture of high performance and impact.

• Oversee objective setting and performance management process among the direct reports. Perform integrated planning, priority setting, and execution of activities fully synchronized with SCQ and local business partners.

• Ensure quality governance and quality planning in the Country organization through the establishment and implementation of the annual Quality Plan, the Country Quality Management Reviews, monitoring of appropriate Key Quality Indicators and Quality Risk Assessments.

• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that support on all quality related matters is provided to the country. Communicate local specific regulatory requirements to Global Quality Assurance to ensure that they are taken into account for global processes, as appropriate.

• Ensure Country organization readiness for GMP/GDP audit and inspection. Ensure adequate GMP/GDP inspection/audit preparation, management, and follow-up. Ensure communication with local Health Authorities is adequately shared within the organization and commitments tracked and closed on time.

• Ensure a local self-inspection program is established.

• Ensure that drug products are released to the market in compliance with the registered specifications, Marketing Authorization and cGMP, and is distributed in compliance with cGDP.

• Ensure that deviations/complaints are investigated, decided and follow-up. That corrective / preventive actions are implemented, as appropriated.

• Ensure that the management of product incidents, product emergencies and market actions, is taken care of in a timely and effective manner. Participate in the global escalations calls and lead the local committees, when needed, to assess local impacts and/or implement decisions from the Global Escalation team. Liaise with all relevant stakeholders.

• Provide quality oversight of local GxP vendors and ensure that they are qualified to perform their activities in compliance with Sandoz Quality Standards.

• Lead of quality systems including compliance to global/local procedures and maintenance of local procedures. Liaise with global quality system owner and where appropriate participate in expert networks and influence within global projects/initiatives.

• Ensure local efficient GxP training program is established.