This is a joint appointment between MyMeds&Me and uMotif – two leading companies supporting the life sciences industry with software solutions. We work separately and together, with significant synergies in technologies, processes and clients.
To lead Quality Assurance for both companies, further developing the existing systems and processes. Preparing for and guiding through any audits from clients or partners.
The role will be split with 3 days per week at MyMeds&Me (Holborn) and 2 days per week at uMotif (London Bridge)
- Ensuring that processes needed for the Quality Management Systems (QMS) are established, implemented and maintained.
- Ensuring that the QMS, and associated documentation, meet all required internal and external Quality and Compliance standards.
- Providing leadership to ensure all System Testing/Verification/Validation is performed in accordance with International Regulatory requirements (e.g. US FDA 21 CFR Part 11, European GMP Annex 11).
- Approval of Quality documentation on behalf of each company.
- Liaison with customers regarding quality/compliance topics.
- Preparation and leadership for customer inspections and on-site audits, including all follow-up activities and remedial actions as necessary.
- Ensuring appropriate assessments/audits of each company’s suppliers and technology partners.
- Reporting to the respective CEO / Quality & Security Committee on the performance of the QMS and any need for improvement. Ensure improvements are fully assessed and instigated as necessary
- Providing appropriate guidance/mentoring to ensure all staff have an understanding of GxP and how the requirements should be applied within each company.
- Partnering with Operations, Development, Testing, Implementation and Support departments to ensure that all aspects of the SaaS products meet the standards required by Healthcare organisations operating within a highly-regulated environment.
- Acting as system manager on key company support systems (eQMS, Training, Document Control) ensuring their continued operation in accordance with appropriate regulations and customer requirements.
- Preparation of key procedural documents, and provision of input to other staff, to ensure that they meet internal and client requirements. Ensure implementation of new or updated documentation follows a consistent path and that relevant staff receive training.
- Ensuring that all Corrective and Preventative Actions (CAPAs) are documented and resolved in a timely manner.
- Relevant experience in an IT-related field or Quality Assurance position within a highly-regulated industry.
- Familiarity with international regulations as applied to the Life Science Industry – Good Clinical, Laboratory, Manufacturing, Pharmacovigilance Practices.
- Understanding of GAMP guidance and the requirements for computer systems validation (CSV) as applied to vendors developing and supporting cloud based SaaS systems.
- Knowledge of software quality principles and familiarity with ‘Agile’ Systems Development Lifecycles.
- Experience of managing internal and external audit programs.
- Demonstrated problem-solving and analytical skills. Good troubleshooting skills and strong attention to detail.
- Strong written and verbal communication.
Nice to have
- Knowledge and understanding of Medical Devices regulations would be an advantage.
- Experience in Data Protection and understanding of the upcoming GDPR.
- Experience with US HIPAA and UK Information Governance.
uMotif is an emerging cloud enterprise software company bringing the next generation patient data capture platform to the life sciences industry. Our goal is to provide clinical research organisations and the broader life sciences industry better patient reported data and insights used to bring the right new therapies to the right patients quicker.
MyMeds&Me are changing the landscape of drug safety data to the benefit of the pharma industry and patients. We are expanding rapidly and currently looking for a Quality Director to join our team in central London. Founded in 2011, MyMeds&Me is a high growth Medtech venture, and our cloud based patient centred solution - Reportum® is deployed by some of the world’s leading pharma brands, including Pfizer.
Why you should join MyMeds&Me
A passionate, driven, growing and friendly team of industry experts make up MyMeds&Me, with one common goal - to simplify adverse event reporting and product quality data capture. Our web-based Reportum solution transforms the end-to-end pharmacovigilance process and our client companies are already seeing the efficiency and effectiveness benefits, finding it increasingly easier to access their safety data and detect critical safety or quality issues as early as possible.
If you are interested in this role please contact:
Andrew Rut, CEO, MyMeds&Me: email@example.com
Bruce Hellman, CEO, uMotif: bruce@uMotif.com