William Smith Email & Phone Number

Frenkendorf, Bl, Ch

Basel, Switzerland

• Lead design, development, maintenance, support, and continuous improvement of regulatory documentation processes, ensuring that they deliver high quality and timely regulatory documentation in line with evolving regulatory authority and internal stakeholder requirements.• Act as a Sustainment Partner for the Roche Regulatory Information Management (RIM) system.• Providing guidance to ensure process continuity, consistency and alignment.• Building and strengthening relationships… Show more • Lead design, development, maintenance, support, and continuous improvement of regulatory documentation processes, ensuring that they deliver high quality and timely regulatory documentation in line with evolving regulatory authority and internal stakeholder requirements.• Act as a Sustainment Partner for the Roche Regulatory Information Management (RIM) system.• Providing guidance to ensure process continuity, consistency and alignment.• Building and strengthening relationships within Roche and with Roche partners to optimise assigned processes.• Providing input/leadership into activities designed to promote continuous improvement and gather broad organisational input to potential process improvements and ideas or opportunities for further innovation.• Responsible for providing relevant input relating to assigned processes to communication, training, implementation, follow-up and feedback groups.• Promoting a culture of continuous process improvement, innovation and a solution-orientated mind set.• Networking with internal and external groups to understanding their needs and ideas, identifying and anticipating solutions and working collaboratively to find solutions.• Ensuring critical process requirements are defined as an input to the development of associated tools and technologies, in partnership with internal and external informatics and IT system roles and providers, where relevant. Show less

Acting in the IT QMS & Compliance role for the new ERP program in Roche implemented in SAP, my responsibilities include:- Definition, planning and supporting efficient quality and validation strategies- Guidance of the ERP implementation teams on regulatory, quality, validation and compliance matters- Training ERP team members on the QMS implemented- Own and define system risk assessments, data classification reports and other project deliverables'

Basel Area, Switzerland

Involved in the compliance of GCP regulated computerised systems to:- Implement quality procedures for the development and operation of computerised systems- Review/approve risk assessment and control activities- Support project phase activities as defined in computerized system validation plans- Support lifecycle processes such as change control and document management- Provide training related to computerised systems quality and compliance

Responsible for managing the pharmaceutical regulatory affairs business process management group and as business project team leader in large document management system delivery projects. Key Achievements:• Designed and delivered Roche’s first full electronic submission to a health authority saving over 200 volumes of paper per filing.• Wrote system SOPs, publishing guidelines, and user manuals that increased the quality and efficiency of system users.• Designed and… Show more Responsible for managing the pharmaceutical regulatory affairs business process management group and as business project team leader in large document management system delivery projects. Key Achievements:• Designed and delivered Roche’s first full electronic submission to a health authority saving over 200 volumes of paper per filing.• Wrote system SOPs, publishing guidelines, and user manuals that increased the quality and efficiency of system users.• Designed and implemented templates for documents and dossiers that maximized the quality of the Roche filings.• Improved system acceptance by providing user support and training.• Represented Roche in the EFPI PIM Implementation Working Group.• Presented at the European CoreDossier User Group and acted as co-host with Novartis of its annual meeting in Basel. Show less

Lead audits of clinical computer systems at Roche and at its external contractors internationally. Performed the Information Management function for the QA department.Key Achievements:• Conducted CSV audits internationally leading to QA improvements and reduced risk of health agency inspection findings that could delay filings.• Developed first set of SOPs for audits of CSV and gave training in them that resulted in standardized audit practices.• Acted as business lead in… Show more Lead audits of clinical computer systems at Roche and at its external contractors internationally. Performed the Information Management function for the QA department.Key Achievements:• Conducted CSV audits internationally leading to QA improvements and reduced risk of health agency inspection findings that could delay filings.• Developed first set of SOPs for audits of CSV and gave training in them that resulted in standardized audit practices.• Acted as business lead in development of a new QA document management system that allowed documents to be shared effectively between the US and Europe.• Qualified as Lead Auditor and registered in the International Register of Certificated Auditors.• Presented to the industry on CSV (Vision in Business, Drug Information Association) and participated in a working party on Computer System Validation (CSV) in Clinical Research that developed a guideline for industry.• Lead a group of clinical auditors from different pharmaceutical companies to define appropriate CSV at investigator sites and published article in Applied Clinical Trials (July 1997). Show less

Delivered software solutions to the Pharmaceuticals Development group.Key Achievements:• Developed programs that allowed the US clinical data system to be used globally in order to providing unbroken support of clinical trials while another solution was being investigated.• Designed a software utility to check the consistency of medical terms glossaries. The results reported identified many inconsistencies which were then eradicated to increase the quality of patient’s clinical… Show more Delivered software solutions to the Pharmaceuticals Development group.Key Achievements:• Developed programs that allowed the US clinical data system to be used globally in order to providing unbroken support of clinical trials while another solution was being investigated.• Designed a software utility to check the consistency of medical terms glossaries. The results reported identified many inconsistencies which were then eradicated to increase the quality of patient’s clinical data records.• Performed system analysis, functional specification and conceptual design of a terms classification system and a system information integration tool providing the basis for later system implementations.• Responsible for implementing a computer systems validation initiative globally. Authored standards and guidelines for the team and gave training at the three HQ sites to gain compliance. Show less

Delivered software solutions for clients in the power and pharmaceutical industry.Key Achievements:• Developed modules a client’s nuclear power station monitoring system that provided fault tolerant system log output and effective alarm message management.• Designed the Case Report Form development feature, as well as software utilities for a clinical trials system. Responsible for system installation and user support.

Delivered software solutions for a client in the marine command and control industry.Key Achievements:• Designed and implemented radar based navigation and helicopter landing guidance features for a client’s coastguard vessel to meet naval contracts.

Designed and delivered telecommunications software for the UK’s first digital telephone exchange.Key Achievements:• Designed a software utility to test hardware faults which increased the reliability of the telephone exchange. Designed a device driver and a crash analysis utility which expedited problem resolution and shortened development times.

Diploma, Research Quality Assurance

Bachelor Of Science, Electrical Engineering

Gce Advanced Level, Mathematics (A), Physics (A), Chemistry (A)