drjobs Head of Country Quality UK/Ireland and Nordics

Head of Country Quality UK/Ireland and Nordics

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1 Vacancy
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Job Location drjobs

London - UK

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Band

Level 6


Job Description 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.


Job Description

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.

Employment Type

Full-Time

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