Head Of Operations, Country Development Qa

Location: Barcelona, Gran Vía, Spain or London, UK. #LI-Hybrid
The main objective of the Head of Operations for Country Development Quality (CDQ) will be to set, deploy and maintain the governance structure, change initiatives, and objectives for CDQ. This role is a critical element for translating strategy into execution for CDQ and will act as a point person to both the CDQ Leadership Team as well as business functions to bridge the distance between global and country operations.
You will be expected to be a key enabler of quality partnership to cross- functional teams and effective interaction with a broad range of colleagues including the various Quality groups, Country Quality leadership, and leadership teams of business functions interacting with CDQ. You will also be critical to assuring that harmonized performance measures are developed, agreed and deployed and discussed to further the ultimate achievement of operational excellence through regular review and analyses of results.
We are open to applications from people happy to based in either our Barcelona or London sites at least 3 days per week.
Key Responsibilities:
Your responsibilities include, but are not limited to:
• Organizational Strategy: Promote the organizational vision, input to team strategy and goals. Support a robust culture of quality across the continuum.
• Governance and Communication: Reinforce governance structure and assure appropriate stakeholder involvement (e.g. Quality Plan, Quality Risk Assessments)
• Performance Measurement: Assure harmonized performance measures are developed, agreed, reported. Perform quarterly trending and follow-up with accountable leaders to assure gaps are being managed appropriately.
• Risk assessment: Own the implementation of the annual Quality Risk Assessment for Good Clinical Practice (GCP) and Pharmacovigilance (PV) activities in countries. Monitor performance and surrogate endpoints to help identify systemic risk and assess areas of improvement and prevention. Ensure that potential gaps and risks are addressed and opportunities for continuous improvements are identified.
• Continuous Improvement and Change Initiatives: Develop standard approaches that lead to a reputation for outstanding quality, collaboration, rigor and follow-through. Identify appropriate continuous improvement initiatives for quality and compliance related areas that add value and reduce dependency on overly complex solutions.
• Upskilling and Training: : Identify and build a library of solutions required for the upskilling of the team. Oversee the development, implementation and management of a robust training program and curriculum for staff across CDQ. Maintain global process applicability listings for CDQ roles.
• Quality Partnership: Represent country-level perspective on key governance board and project teams to assure that country level needs and feedback can be seamlessly input to global process and decision-making. Report on the outcome to drive transparency and effective use of resources for global projects and initiatives.
• Member of the CDQ Leadership team.
Key Performance Indicators (KPIs)
• Implementation and regular review of Key Quality Indicators with CDQ Leadership team and at governance boards to proactively identify areas of potential risk and opportunities for continuous improvement.
•Timely and effective preparation and management of metrics, trending, risk assessments, training curriculum, etc. as above.

Essential Requirements:
• Global Clinical Trial Set-up, Management & Conduct.
• Global Health Authorities experience.
• Strong experience in International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP.
• Extensive European Medicines Agency (EMA)/Medicines and Healthcare Products Regulatory Agency (MHRA) & Food and Drug Administration (FDA) experience including Inspection preparedness.
• Understanding of trending and analytics to predict outcomes and simplify processes.
• Knowledge of Total Quality Management (TQM) and related industry GxP standards and processes.
• Global Quality & Risk Management.
• A strategic mindset to fully understand what needs to be done to achieve goals.
Desirable Requirements:
• Experience overseeing the development, implementation and management of a robust training programs for staff across countries in collaboration with partners.
• Experience with rolling out Global Clinical Quality processes into Country specific environments.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network