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- Tasks: Lead quality teams across UK, Ireland, and Nordics to ensure compliance and optimise processes.
- Company: Join Novartis, a global leader in pharmaceuticals committed to inclusivity and community impact.
- Benefits: Enjoy a supportive work environment with opportunities for personal and professional growth.
- Why this job: Make a real difference in healthcare while collaborating with passionate professionals.
- Qualifications: 15+ years in Quality within a global pharma, with strong leadership and regulatory expertise required.
- Other info: Flexible working arrangements and commitment to diversity and inclusion.
The predicted salary is between 43200 - 72000 £ per year.
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
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.
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.
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.
Head of Country Quality UK/Ireland and Nordics employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Country Quality UK/Ireland and Nordics
✨Tip Number 1
Familiarise yourself with Novartis' core values and quality standards. Understanding their commitment to quality and compliance will help you align your experience with their expectations during discussions.
✨Tip Number 2
Network with current or former employees of Novartis, especially those in quality roles. They can provide insights into the company culture and what it takes to succeed in the Head of Country Quality position.
✨Tip Number 3
Prepare to discuss your experience with regulatory bodies and inspections. Highlight specific examples where you've successfully navigated audits or improved compliance processes, as this is crucial for the role.
✨Tip Number 4
Stay updated on the latest trends and regulations in the pharmaceutical industry, particularly in the UK and Nordics. This knowledge will demonstrate your proactive approach and readiness to lead quality initiatives.
We think you need these skills to ace Head of Country Quality UK/Ireland and Nordics
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality management within the pharmaceutical industry. Emphasise your leadership skills and any experience with regulatory compliance, especially in GMP/GDP.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about quality assurance in pharmaceuticals. Mention specific achievements that demonstrate your ability to lead teams and manage complex quality processes.
Highlight Relevant Experience: When detailing your work history, focus on roles that involved managing multinational teams and collaborating with health authorities. Use metrics to showcase your impact, such as improvements in compliance rates or successful audits.
Showcase Your Communication Skills: Since effective communication is crucial for this role, provide examples of how you've successfully communicated quality matters across different levels of an organisation. This could include leading meetings, writing reports, or presenting to stakeholders.
How to prepare for a job interview at Novartis
✨Showcase Your Leadership Experience
As the Head of Country Quality, you'll need to demonstrate your leadership skills. Prepare examples of how you've successfully managed multinational teams and driven quality initiatives in previous roles.
✨Understand Regulatory Standards
Familiarise yourself with EU/UK GMP/GDP regulations and any recent changes. Be ready to discuss how you have ensured compliance in past positions and how you would approach this in the new role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in complex scenarios. Think of specific instances where you navigated challenges between different regions or departments and how you achieved successful outcomes.
✨Emphasise Communication Skills
Effective communication is key in this role. Be prepared to discuss how you have facilitated information flow between teams and health authorities, especially during inspections and audits.
