The QMS Manager role will guide and support Business Groups, Markets and enabling functions, and will drive QMS compliance during the Quality "Accelerate" Transition program; ensure that QMS processes comply with regulations. You will secure that the QMS is consistent and check the effectiveness of the QMS processes.
As the QMS Manager, you will be involved in the QMS integration of the domains Personal Health, including Sleep & Respiratory, Diagnosis and Treatment, and Connected Care and Health Informatics. This results in a highly visible position right in the centre of the action.
- Maintains, enforces, and manages a compliant and effective Markets OneQMS, one overall quality management system applicable for multiple internal organizations
- Maintains an effective and lean Market OneQMS structures
- Leads the transition of standalone QMS's into the Markets OneQMS
- Manages transition of E2E programs into the Markets OneQMS, while maintaining compliance and effectiveness throughout the duration of the transition to the Markets OneQMS
- Ensures traceability OneQMS and the Markets OneQMS
- Acts as the Business contact towards suppliers, including monitoring of budgets, for Market Translation activities
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that's not all. Quality is right on the top leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role's mission, you will have an array of diverse career options open to you - across different functional areas, product lines, business groups and/or geographies.
Skills and Experience:
- A seasoned, experienced professional with a full understanding of ISO 9001, ISO 13485 and 21 CFR 820. Preferably knowledge of ISO 9001:2015 and ISO13485:2016
- Project management experience, leading complex projects where not directly responsible for all required deliverables
- Across all levels and cultures of the organization, strong communication and influencing skills to enable effective implementation and execution of job responsibilities
- Able to analytically assess impact to the Markets OneQMS and the local organization of E2E programs, including the ability to understand and develop processes.
- Able to proactively and independently resolve issues in creative ways
- Flexible in working hours due to the global scope
- A hands-on mentality
- Highly proficient in spoken and written English
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sayf Jabbar on +44 203 8281 920 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.