ProClinical is currently recruiting on behalf of a leading global pharmaceutical company that specialises in multiple therapy areas. They are currently looking to recruit a QMS Manager to work in London on a contract basis. The organisation offers an excellent rate of pay and have a strong reputation as an excellent company to work for.
- Supports the QMS lead position in ensuring that the organizational structure, responsibilities, procedures, processes and resources for the business Quality Systems and implementation of Quality compliance activities are communicated and implemented to meet the needs of GRA and conform to all applicable regulatory requirements
- Responsible for the ongoing development, maintenance and support of the global Quality Management System (QMS).
- Acts as subject matter expert and project lead for multiple projects to drive continuous improvement of systems.
- Facilitates the process to reach harmonized and streamlined processes which meet business needs.
- Ensures that personnel are aware and responsive to external guidelines and regulations as they pertain to quality management and compliance.
- Coordinates and participates in audits and inspections in GRA.
- Works to ensure compliance for the Regulatory Organization, including internal and external teams and partners.
- Participates in the creation, review, approval and lifecycle management of controlled quality documents (e.g. SOPs) and supporting documents within Global Regulatory Affairs.
- Ensures internal review of QMS documents from other functional areas
- Analyses and communicates compliance metrics, ensuring communication of oversights.
- Make recommendations of quality improvements across GRA.
- Develops and delivers training materials describing system related business processes.
- Plans and ensures end-user training is conducted globally and locally.
- Advises on the use of the global QMS in daily business work- Manages, maintains and implements QMS documents with RA functions, which reflects best regulatory practice focusing on factors such as business need, resources and methods
- Assists the regulatory sub-functions in the development and maintenance of appropriate individual training matrices for regulatory affairs staff
- Participates in the development of common procedure across the different functions within GRA
- Manages Quality Investigations in collaboration with relevant stakeholders establishing effective and timely CAPAs
- Partners with R&D QA and interface with all disciplines in the identification and understanding of the interfaces between the different functions in respect to QMS.
Skills and Requirements:
- Bachelor’s degree (or equivalent) required. Masters preferred.
- Significant experience in Pharmaceutical industry, in Regulatory Affairs, research and development or quality assurance/compliance.
- Strong QMS experience.
- Experience in the development, implementation and maintenance of a QMS
- Demonstrated knowledge of pharmaceutical and regulatory affairs requirements and practices
- Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets.
- Practical operational experience of working across disciplines and across multiple regions.
- Experience working within a global team framework and a multi-cultural environment.
- Ability to work independently and focus on multiple issues/deadlines simultaneously.
- Ability to critically analyse complex and/or ambiguous information and the impact on products and process.
- Ability to effectively communicate complex issues both verbally and in writing.
- Excellent analytical, technical and problem-solving skills (TQM or Six Sigma experience preferred.
- Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
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 Joseph Emmott on +44 203 8141 316 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.