In this role, you have the opportunity to provide significant leadership and input into the growth of a leading-edge solution provider to the health sciences market worldwide.
You are responsible for:
· Ensuring that processes needed for the Quality Management System (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 MyMeds&Me.
· 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 MyMeds&Me suppliers and technology partners.
· Reporting to the 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 MyMeds&Me.
· Partnering with Operations, Development, Testing, Implementation and Support departments to ensure that all aspects of our SaaS product 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.
You are a part of the management team in a young, dynamic software development company providing services to global pharmaceutical companies and regulators. You will report directly to the CEO and will be expected to promote a quality culture, meeting the expectations of our customers, throughout the company.
To succeed in this role, you should have the following skills and experience:
· 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 and 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.
· Knowledge and understanding of medical devices regulations would be an advantage.
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.