Roger Warde's Email Addresses & Phone Numbers

A highly motivated and competent Technical and Quality Manager with 18 years experience of working with finished product manufacture within the pharmaceutical sector. A Six Sigma Black Belt, confident working in a GMP/GDP environment within the regulatory constraints and quality requirements of the industry. A proven track record of leading teams and delivering projects stretching across sites,...

A highly motivated and competent Technical and Quality Manager with 18 years experience of working with finished product manufacture within the pharmaceutical sector. A Six Sigma Black Belt, confident working in a GMP/GDP environment within the regulatory constraints and quality requirements of the industry. A proven track record of leading teams and delivering projects stretching across sites, and cultures. In depth experience of working with third party manufacturers. A competent and diligent auditor, leading audits and tracking compliance remediation programs for organisations. Designated Responsible Person (RP) for WDL.Associate Director @ Develop and maintain quality/regulatory compliance programs to assure GMP compliance on a global and corporate-wide level in a rapidly growing biotech company directing compliance staff and all internal and external compliance assessments and to communicate and mitigate regulatory compliance risks to the corporation. • Global supplier compliance program to include raw materials, components, software, contractors, distribution partners and internal manufacturing and testing operations. • Supplier change management process to ensure proper assessment of proposed changes to raw materials and components. • Manage response tracking system to ensure that it is maintained as current and that responses to regulatory observations are executed in accordance with the commitment and by the target date specified. • Ensure on-going inspection readiness, adherence to audit schedules, and the generation of periodic status reports for each function managed. • Serve as lead for the product recall program to include periodic execution of mock recalls. • Quality/technical agreements with distribution partners. Build and maintain knowledge management systems in accordance with ICH Q10. Plans and directs work activities, continuously monitors and reports on progress, to ensure department goals and commitments are accomplished efficiently and within established timeframes. Facilitates and oversees development and continuous improvement of compliance initiatives. Interacts effectively with company management both internal and external to ensure compliance commitments are understood and adhered to. Develop and manage budgets for the GMP Compliance Department. Manage and develop staff located in multiple, remote locations. From May 2013 to Present (2 years 8 months) London, United KingdomSr. Manager @ • To ensure continuous GMP/GDP, regulatory, and compliance with BioMarin quality requirements through periodic assessments and/or audits of domestic and international Third Parties (i.e. Suppliers, Contract Manufacturers, Contract Laboratories, Commercial Distribution Partners and key Service Providers) providing materials and services for the manufacture, storage and distribution of GMP regulated Clinical material and Commercial finished products in Europe, the Middle East and Asia. • Responsibilities include: - Responsible Person for the organisation. - Regional systems development, global systems integration, and related training e.g. - Resourcing and execution of regional audits for suppliers and distribution partners (both ambient and cold chain storage). - Mapping of the Supply chain for BioMarin product portfolio to ensure traceability and security. - Inspections/Inspection readiness activities for the London office. - Supplier and Distribution Partner audit activities including scheduling, conducting, reporting, tracking responses, and closure. - Supplier Compliance quality metrics including periodic reporting of metrics to management. - Supplier Management improvement projects e.g. risk based approach to the Supplier Management Program. - Global integration of BioMarin procedures. - Review of Supplier and Distribution Partner complaints. - Review of returns and their disposition according to GDP principles. - Review of Quality & Technical agreements during audit activities. - Review, control and approval of Bona fides via public registers, Service and Quality Agreement review, documentation collation and questionnaire submission. - Approved Supplier List maintenance. - Maintenance of Supplier audit history files. - Supplier Evaluations and development of a risk management tool for supplier evaluation. - Member of the recall team. - Collation of Pharmacovigilance SOPs and line listing from Distribution Partners. From June 2011 to Present (4 years 7 months) Technical Project Manager @ From November 2010 to May 2011 (7 months) Quality Manager @ From December 2009 to November 2010 (1 year) Sr Manager @ From 2008 to 2009 (1 year) IMP Manufacturing Manager @ From 2005 to 2008 (3 years) Pharmaceutical Scientist @ From 2000 to 2005 (5 years) Purification Scientist @ From 1998 to 2000 (2 years) Scientist @ From 1995 to 1997 (2 years) Master of Science (MSc) @ The University of Manchester Roger Warde is skilled in: IND, Lifesciences, NDA, Oncology, GxP, Validation, FDA, CMC, Purification, ISI Toolbox, Drug Development, Clinical Trials, LIMS, Sop, CAPA