Quality Management System Lead WHO WE ARE Datapharm is a fast-growing technology firm and SaaS provider in the healthcare space. Our medicines information database, emc (electronic medicines compendium) is the UK's most comprehensive, trusted and accessible source of information on medicines. We provide innovative solutions to support the Life Sciences and wider Healthcare sectors, serving more than 350 Pharma customers in the UK.
THE JOB ROLE The Quality Management System Lead will create the quality standard for Datapharm, ensuring that our employees and operational processes and procedures maintain ISO9001 certification. In addition, the QMS Lead will be leading on the implementation of the new eQMS, working with the business to ensure a smooth transition and adoption of the system and new ways of working. Duties will include monitoring performance, creating compliance reports and collecting feedback from employees and clients. The QMS Lead will report to the Security and Compliance Lead.
As we are looking to develop our QMS using a new electronic system, it is essential that the successful candidate has experience of supporting and/or implementing a QMS that meets ISO9001 standards.
Please note this is a hybrid role and you will be required to visit our office in Leatherhead two days a week.
WHAT YOU'LL DO Develop, implement and maintain the Datapharm eQuality Management System. Design quality standards, procedures and specifications for Datapharm. Develop a quality control process to meet the needs of internal and external stakeholders, including the management of document templates. Maintain quality certifications (ISO9001) with a practical approach adopted in terms of training and monitoring, record keeping and documentation (including the Information Asset Register and Supplier Review records). Ensure visibility and continuous improvement of Quality System processes across the business. Review existing processes and procedures to ensure they align with Datapharm's purpose and strategic direction. Maintain documentation of procedural changes. Prepare performance reports for relevant stakeholders (Exec). Manage the Business Risk process to ensure it is kept up to date and relevant. Manage third party supplier lifecycle. Lead on all internal and external audits, conduct inspections and quality reviews to identify areas for improvement. Collaborate with external vendors and suppliers to ensure that they meet quality standards. Manage any non-conformances identified, ensuring corrective action plans are developed and implemented. Oversee and advise on the quality plans for different functional areas in the business to ensure a coordinated approach to meet the Quality. ABOUT YOU The following expertise and experience are required:
A strong understanding of Quality standards and regulations (ISO9001, ISO27001, etc.). ISO9001 Internal Auditor certification is desirable. Organised with high attention to detail. Excellent verbal, written and interpersonal skills. Strong stakeholder engagement skills. Strong change management skills. Strong analytical and integration skills. Proactive and self-motivated, able to set and achieve personal targets. Comfortable working in a small, fast paced company. Able to work effectively with others in a group and participate in new ideas generation. Results orientated. Demonstrate that you can think your way out of a problem/challenge using your own initiative. ABOUT DATAPHARM Datapharm is the leading medicines information provider in the UK. Our medicines information database, emc (electronic medicines compendium) is the UK's most comprehensive, trusted and accessible source of information on medicines. emc is used by the NHS daily, lists more than 10,000 medicines and attracts a growing audience of over 50 million visitors per year.
We partner with a wide range of professional and voluntary health organisations to improve health literacy and decision making about medicines for patients, carers, healthcare professionals and the pharmaceutical industry.
Our Mission Our mission is to improve the accessibility, effectiveness and excellence of healthcare product information.
We do this through our expertise in medicines information, providing regulatory, compliance and commercial software solutions to the pharmaceutical industry. This enables the delivery of trusted and accessible medical information to, and increased engagement with, healthcare professionals and patients.
Our Values We Care for colleagues and customers by acting with integrity, responsibility, and mutual respect. We Collaborate to ensure a shared commitment to goals which are based on customer impact and success. We have the Courage to create positive change, be open to new challenges and learn new skills. Don't meet every single requirement? At Datapharm we are dedicated to building a diverse, inclusive, and authentic workplace, so if you are excited about this role but your experience does not align perfectly with everything in the job description, we still encourage you to apply. You may be just the right candidate for this role or another within the company.
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