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.
• 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
• 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.

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.

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.

• 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.
• 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.

• 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.
• 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.

• 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.
• 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.
• 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.

Diploma, Research Quality Assurance

Bachelor Of Science, Electrical Engineering

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