Head of Quality
Location: United KingdomSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Slough United Kingdom.
- Deal with complex issues using critical analysis and develop ethical, reasoned solutions to meet both business and regulatory requirements
- Impact and influence the organisation by communicating quality issues and decisions which impact the business
- Ensure compliance of suppliers Third Party Distribution to all company requirements including distribution and transportation
- Ensure continuous improvement activities for more effective Quality systems across the organisation
- Ensure quality alignment to company business growth objectives
- Ensure that a Quality system management is implemented and maintained
- Support audits of the distributor warehouse facilities and secondary packaging facilities
- Assure correct tracking of quality complaints in the internal database
- Communicate the outcome of investigations to complainant, as appropriate
- Ensure all quality trainings are in place and carried out for company employees
- Assure timely notification of quality deficiencies / complaints of medicinal products internally and to relevant Health Authorities, as appropriate
- Support Supply Chain to avoid / end back orders
- Support Supply Chain for timely redressing
- Organise recalls
- Maintain Quality Manual
- Ensure inspection readiness
- Be the Responsible Person UK
- Progressive managerial experience within the quality control function of the pharmaceutical health care industry and regulatory agencies
- Extensive knowledge and experience in pharmaceutical health care operations, quality control, distribution and International regulations are essential
- Proficient in cGMPs, cGDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations; and requirements for pharmaceutical products distribution
- Demonstrated ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
- Good verbal, written and presentation skills in English; the ability to deal effectively with all levels of management
Innovative, creative, and able to utilize available resources
- Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint and SAP) and in Quality Systems
- Team oriented worker with excellent interpersonal skills
- Demonstrated ability to switch priorities plus manage more than one project at the time. Ability to plan and conduct projects within a multi disciplinary environment, inquisitive, science technology oriented individual but practical
- Demonstrated ability to influence, collaborate, and communicate directly, and to lead cross functional and cross regional teams
- Strong negotiating skills in order to interface with regulators and external Quality Assurance business. Demonstrated ability to effectively communicate ideas, lead and persuade others to accomplish challenging goals and objectives
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
The Company
We are looking for a Head of Quality for one of our Pharma clients in the Slough area.Role Description
The Head of Quality UK & Ireland is responsible for ensuring that a quality management system is implemented and maintained for the distribution activities with all products in the respective markets.Responsibilities
- Lead the implementation of the quality system, including the organisation and the documentation as well as tracking the completion milestones- Deal with complex issues using critical analysis and develop ethical, reasoned solutions to meet both business and regulatory requirements
- Impact and influence the organisation by communicating quality issues and decisions which impact the business
- Ensure compliance of suppliers Third Party Distribution to all company requirements including distribution and transportation
- Ensure continuous improvement activities for more effective Quality systems across the organisation
- Ensure quality alignment to company business growth objectives
- Ensure that a Quality system management is implemented and maintained
- Support audits of the distributor warehouse facilities and secondary packaging facilities
- Assure correct tracking of quality complaints in the internal database
- Communicate the outcome of investigations to complainant, as appropriate
- Ensure all quality trainings are in place and carried out for company employees
- Assure timely notification of quality deficiencies / complaints of medicinal products internally and to relevant Health Authorities, as appropriate
- Support Supply Chain to avoid / end back orders
- Support Supply Chain for timely redressing
- Organise recalls
- Maintain Quality Manual
- Ensure inspection readiness
- Be the Responsible Person UK
Requirements
- Must possess a Master’s Degree in Sciences, preferable in Pharmacy or Life Sciences with appropriate experience- Progressive managerial experience within the quality control function of the pharmaceutical health care industry and regulatory agencies
- Extensive knowledge and experience in pharmaceutical health care operations, quality control, distribution and International regulations are essential
- Proficient in cGMPs, cGDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations; and requirements for pharmaceutical products distribution
- Demonstrated ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
- Good verbal, written and presentation skills in English; the ability to deal effectively with all levels of management
Innovative, creative, and able to utilize available resources
- Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint and SAP) and in Quality Systems
- Team oriented worker with excellent interpersonal skills
- Demonstrated ability to switch priorities plus manage more than one project at the time. Ability to plan and conduct projects within a multi disciplinary environment, inquisitive, science technology oriented individual but practical
- Demonstrated ability to influence, collaborate, and communicate directly, and to lead cross functional and cross regional teams
- Strong negotiating skills in order to interface with regulators and external Quality Assurance business. Demonstrated ability to effectively communicate ideas, lead and persuade others to accomplish challenging goals and objectives
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
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