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Head of country quality uk/ireland and nordics

Dalkeith
Novartis
Posted: 20 June
Offer description

Job Description

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Summary The Head of Country Quality UK/Ireland and Nordics leads the Country Quality Teams (NCQ) within a Commercial Organisation (CO) covering UK, Ireland and Nordic countries. It is to drive the Quality agenda within the CO in line with Global, Regional and Country needs. To direct and lead the Country Quality organization to enable development of effective quality values, standards and culture (right first time). To ensure compliance to all regulatory standards (GMP/GDP) and lead the hosting of the relevant health authorities' inspections and global audits, to ensure transparency and enhance relationships with global and local health authorities. Lead the optimization of quality processes in the CO, ensuring quality governance and quality planning in the Country organization through the implementation of adequate quality systems, processes, the annual Quality Plan and Risk assessments. This will help to prevent quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays all of which would negatively impact the financial performance of the company as well as the reputation. About the Role

Deadline for applications: 1st of July 2025.

Major accountabilities:

* CO Leadership - as a key member of the Country Organisation Leadership Team UK (CCC) works with other CO executives to deliver highest possible quality market presence and ensure the quality standards of Novartis products.
* Leads the commercial quality contribution to CO strategy and risk management and ensures compliance with regulatory standards (GMP/GDP) across business units in UK, Ireland and the Nordic region.
* Collaborate with the local Country Development Quality (CDQ) organization where processes are shared or inter-related to ensure compliant implementation, maintenance and upgrading of the local Quality System and Standard Operating Procedures.
* Ensure quality governance and quality planning in the UK, Ireland and Nordic region Country organizations through the establishment and implementation of the annual Quality Plan, the Country Quality Review Board, appropriate Key Quality Indicators, and Quality Risk Assessments.
* Accountable for efficient information flow and effective communication of all relevant quality matters, from the country to the Global QA organization and vice-versa including but not limited to issue escalation.

Minimum Requirements:

* Education: Degree in pharmaceutics or related Life sciences. It is required eligibility to act as a Qualified Person (2001/83/EC or HMR 2012/1916 UK).
* Minimum of 15 years' experience in Quality department in a Global Pharmaceutical Company.
* Excellent leadership skills with proven experience in managing multinational teams.
* Experience in both Commercial and IMP Product release.
* Expert in EU/UK GMP/GDP, awareness of UK and EU GCP and Pharmacovigilance requirements.
* Strong team player and flexibility managing complex scenarios between the cluster and region.
* Solid experience in hosting and building relations with health authorities / regulatory bodies, especially during inspections and global audits.
* Fluent English, written and spoken.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Novartis Life Handbook

Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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

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