Associate Director of Operations, Innovative Technology, Country Development Quality

Job Description Summary

Locations: Barcelona, Spain ; London, United Kingdom ; Dublin, Ireland
This exciting new opportunity sits in the intersection between technology, quality, governance and metrics. The workload is varied, even on a day-to-day basis, and there will be lots of challenges and problems to solve along the way with innovative thinking and new approaches. You’ll get an insight into the full development process from first dose in man, to clinical, safety and pharmacovigilance data. In this non-typical QA role we are looking for someone that is technically savvy and able to leverage tools like Power BI and AI, to help automate some of the information reporting and to point to proactive indicators to enable the business to operate better, and to draw more accurate conclusions across all of these drug development stages.

 

Job Description

Key Responsibilities:

• The main objective of the Associate Director of Operations for Country Development Quality (CDQ) will be to support and maintain the governance structure for the CDQ Leadership Team including tracking quality planning, objectives, and change initiatives, with a focus on the use of new technologies to help automate and improve reporting and analysis.

• This role is a fundamental element to assure CDQ executes on key deliverables. The AD will work closely with the Director of Ops and Compliance in CDQ, the CDQ Leadership Team and will partner across quality and business functions to help mitigate the knowledge gap between global and the country levels.

• Enable and maintain quality partnership to cross-functional teams and should effectively interact with a broad range of colleagues including the various Quality groups, Country Quality leadership, and leadership teams of business functions interacting with CDQ.

• Instrumental in the implementation of a clear methodology to identify and assess risks across countries for clinical and pharmacovigilance-related activities.

• Assuring that harmonized performance measures are deployed and discussed to further the ultimate achievement of operational excellence through regular review and analyses of key results (i.e. KPIs and KQIs).

• Responsible for recommending and launching new initiatives to support continuous improvement, sharing of lessons learned and best practices in relation to clinical and pharmacovigilance quality activities.

• Oversee the assignment, implementation and compliance to required training (i.e. SOPs, AE training) for CDQ staff across countries in collaboration with partners across Research and Development Quality and with business line functions.

Essential Requirements:

• University degree in Life Sciences, Pharmacy, Medicine or Business management with commensurate experience.

• A demonstrable level of experience in GCP and/or PV Quality Assurance, project management or a combination of the two disciplines.

• Leadership experience and accomplishments in a global/matrix environment. Strong management and interpersonal skills.

Desirable Requirements:

• Strong business stakeholder management, leading, negotiating and influencing in a matrix environment. Strong project management skills; considerable organizational awareness. (e.g. interrelationships between functions and business priorities). Ability to interact with Senior Business Leaders on a regular basis to align strategic direction.

• Strong industry network

• Experience with reporting toolsets such as PowerBI and new approaches using AI

Why Novartis?

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy /people-and-culture 

Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Accessibility & Accommodation : 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

 

Skills Desired

Auditing, Audit Management, Business Partnerships, Continued Learning, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, ISO 9001, Leadership, Organizational Savvy, People Management, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Speed and Agility Training, Stakeholder Management, Technical Knowledge, Vendor Management