Location: United Kingdom Frimley/Camberley
Closing Date: 08 Dec 16
Type: Full Time
Salary (£): On Application
Head of Quality, Novartis, UK Job Summary: Do you want to work for a Global Pharmaceutical company where you will get recognized for your hard work and commitment? Look no further, apply today. Job purpose: The purpose of this role is to develop an industry leading CPO Quality organization (Commercial, Quality Systems and Development). It is to drive the Quality agenda within the CPO in line with Global, Regional and Country needs. ...
Head of Quality, Novartis, UK
Do you want to work for a Global Pharmaceutical company where you will get recognized for your hard work and commitment? Look no further, apply today.
The purpose of this role is to develop an industry leading CPO Quality organization (Commercial, Quality Systems and Development). It is to drive the Quality agenda within the CPO in line with Global, Regional and Country needs. You will direct and lead the CPO Quality organization to enable development of effective quality values, standards and culture (right first time). You will ensure compliance to all regulatory standards and lead the hosting of health authorities’ inspections and global audits, to ensure transparency and enhance relationships with global and local health authorities. You will also lead the optimization of quality processes in the CPO, ensuring quality governance and quality planning in the Country organization through the implementation of adequate quality systems, processes, the annual Quality Plan, Risk assessments and modules. 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.
• CPO Leadership - As a key member of the Country Pharma Organisation Leadership Team (CPOLT) works with other CPO executives to deliver highest possible quality market presence and ensure the quality standards of Novartis products
• Leads the quality contribution to CPO strategy and ensures compliance with regulatory standards across franchises and business units
• Collaborates with Regional and Global colleagues to input and develop quality plans and strategy both within country and at Regional / Global level. Quality Management, Product, Development and systems - Accounts for full regulatory and compliance adherence across all quality activities at Country level (including General Medicines and Oncology)
• Lead the local QA organization to ensure implementation, maintenance and upgrading of the local Quality System and Standard Operating Procedures in order to drive compliance of all GXP and Pharmacovigilance related processes and tasks with local/International regulatory requirements and the Novartis Quality Manual.
• Ensure quality governance and quality planning in the Country organization through the establishment and implementation of the annual Quality Plan, the Country Quality Review Board, appropriate Key Quality Indicators, and Quality Risk Assessments.
• Lead the Quality Committee - Accountable for European centralized release across 50 countries
• Accountable for training oversight and quality compliance across all business units for both Gen Med and Oncology
• Ensure Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and quality & compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV)
• Ensure an adequate Escalation Process is effective and used, in compliance with Novartis policy
• Accountable for efficient information flow and effective communication of all relevant quality matters within the CPO organization, from the country to the Global QA organization and vice-versa including but not limited to issue escalation.
Our mission is to care and cure; We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life. We also want to provide a shareholder return that reflects outstanding performance and to adequately reward those who invest their money, their time and their ideas in our company.
Benefits of Working for Novartis:
Strong Work/Life Balance, flexible working
Top UK Employer
Comprehensive Medical Insurance
Employee Recognition Scheme
Sports & Social Club
‘I came for the job, I stay for the culture’
#LI-P Minimum requirements The ideal candidate will have:
• Degree in pharmaceutics or related Life sciences
• Proven experience in managing multinational teams
• Responsible for both Development and Product release across all GxPs
• Strong experience in hosting health authority inspections and global audits
• Demonstrated experience in building quality management systems.
• Strong knowledge in GCP and Pharmacovigilance
• Experience in building relations with Health authorities and regulatory bodies
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons
Novartis Pharmaceuticals UK Limited
Frimley Business Park
|Tel:||+44 (0)1276 692255|
|Fax:||+44 (0)1276 692508|
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