Director IT Validations - Pharma - BioTech

Location: South San Francisco, CA 94080 Employment Type: Full Time, Employee Pay Rate: 140,000.00 - 160,000.00 USD /year The Director IT Validation shall manage and lead all aspects of the IT validation and qualification activities relating to Global Development GxP IT Systems. This individual shall be the primary liaison between the Global IT Organisation and the Quality Assurance Groups covering all aspects of IT Systems validation ensuring the the continuous delivery of a high quality, compliant and cost-effective service to Elan. Responsibilities: 'Manage, lead and co-ordinate as necessary all activities relating to the validation and qualification of all GxP IT Systems Develop and maintain the inventory of Global Development GxP IT systems supported by the IT Department. 'Develop validation project plans for new systems and ensure the effective maintenance of the validated state of existing IT systems. 'Ensure that all documents required for the successful execution of the validation project plan are appropriately developed, completed and presented to QA for review and approval. This shall involve working with the IT I&O and IT Applications Groups to ensure all necessary technical specifications and related documents are developed and, the system owner to ensure the successful execution of the performance qualification. 'Liaise with QA to ensure the effective execution of a periodic review of all relevant IT systems and the timely close-out of all identified tasks. 'Lead or participate as required in the audit of external vendors and facilitate as necessary audits of IT by external parties ensuring the timely and effective resolution of all identified issues. 'Advise system owners and management on compliance risks within the organizations and provide effective solutions for mitigating risks and issues. 'Provide subject matter expertise on all aspects of the IT system validation lifecycle, provide effective mentoring to all members of the IT Validation Group and maintain awareness across all IT groups of validation principles and practice. 'Participate or lead where appropriate, in the development and review of policies, standards, templates, and procedures in the areas of IT Systems validation. 'Ensure the effective and efficient operation of all IT validation processes and where necessary develop or improve key processes and 'Compile and report IT Validation metrics in line with management reporting requirements. 'Stay abreast of current regulatory requirements in the area of computer validation across all relevant geographies and ensure the ongoing compliance of all associated IT processes.  'University Degree or equivalent plus relevant academic qualifications in relevant discipline. '5-10 years experience working in the area of IT systems validation and 2-3 years leading an IT Validation group preferably in a BioTech GCP focussed environment. 'Training in IT System Development Lifecycle Methodologies. 'IT Project Management 'IT System Testing Methodologies. 'Detailed knowledge of and practical implementation of ISPE Commissioning and Qualification Guidelines, GAMP, ASTM E2500 guideline, 21 CFR Part 11 and ICH Q8, Q9 and Q10. 'Ability to influence & negotiate with teams from all levels of the organisation and external suppliers 'Ability to read, analyse and interpret business plans, technical procedures, and governmental regulations. 'Proven analytical and problem resolution skills. 'Excellent communication skills at the functional, technical, and executive level. 'Ability to understand complex business processes 'Ability to work as part of a "virtual" team. 'Experience in computer hardware and application testing and documentation 'Knowledge of testing principles, processes and procedures 'Understanding of all phases of Software Development and Validation 'This position requires strong verbal and written communication skills, knowledge of Microsoft Office products (Word, Excel, PowerPoint, Project and Visio) 'Professional body or Special Interest Group memberships is desirable.