Sector: Life Sciences
Consultant: Harvey Havell
Salary: £65000 - £71500
Job Status: Permanent / Full Time
Job Title: Head of Quality
Reporting to: Head of Product and Process Innovation
Department: Research, Medical and Innovation
Location: Victoria, London
Hours: 40 hours but will consider potentially 4 days a week and occasional home working
Package: Up to £71500, 8% bonus, 10% pension, health/travel/life cover
Job Purpose and Background
My client represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. We represent companies who supply more than 80 per cent of all branded medicines used by the NHS and who are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
Recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements including the pricing scheme for medicines in the UK.
Reporting to the Head of Product and Process Innovation, the primary responsibility of the Head of Quality is to manage issues relating to the operational aspects of pharmaceutical quality and quality related aspects of product development as they affect the companies. This includes finished product and clinical trial manufacturing, good manufacturing practice and quality standards. In particular, the role holder will have a significant involvement in the development of the new medicines manufacturing and quality regulatory environment for the United Kingdom and the EU following the UK withdrawal from the EU.
The role also oversees all matters relating to environmental, health & safety and chemicals legislation and government policy at UK and EU levels as they affect pharmaceutical manufacturing and quality.
The role also provides support to the Medicines Manufacturing Industry Partnership (MMIP).
The role holder will
- Provide Industry Thought Leadership on operation aspects of pharmaceutical quality, quality related aspects of product development and to environmental, health & safety and chemicals legislation and government policy
- Horizon scanning for proposals for new legislation and implementation of current legislation and consultation of member companies on such proposals
- Active involvement in UK and European Networks – particularly, effective engagement in the work of EFPIA and liaison with other Trade Associations with similar interests to ensure member companies needs are represented
- Influence Policy through collaborative working with regulators both nationally and internationally
- Working with Members – particularly management and co-ordination of the Association Expert Networks on Pharmaceutical Quality and Environment, Health & Safety
- Cross functional working with other colleagues within the company
- Support for media responses the areas outlined above
- Support MMIP activities and meetings
Skills, Experience and Qualifications
- Science based degree – preferably life sciences or chemical
- Significant experience gained in a regulatory, quality or development/manufacturing environment within the bio/pharma industry
- Previous involvement with or experience of working in a Trade Association environment
- Media experience is desirable
- Thorough knowledge of (and the ability to learn and keep abreast of) relevant regulatory processes, UK Medicines Act legislation and EU/International medicines and environmental legislation, British and International standards and other regulations
- Business and Commercial focus (a working knowledge of trade regulations and procedures would be a plus)
- Good judgment and initiative: be able to decide on which issues a response can have the most constructive impact, and quality control the output
- Ability to think strategically/conceptually/progressively, desire and ability to work hands-on, on a multi-task/priority basis in addition to the broader strategic activities
If this is of interest, please click apply now to submit your CV. If you need anymore info on the role, please ask for Harvey in the Life Sciences team.