David Stanmore Email & Phone Number

Basel, Ch

Leading the QA, QC and Validation functions for the site and ensuring compliance with all regulations, global quality requirements and meeting customer expectations. Restructured and realigned the Quality Unit, a team of 180. Successfully hosted all regulatory inspections eg MHRA, USFDA, ANVISA, PMDA, Health Canada etc. Implementation of a Sustainable Compliance (remediation) program, now full QRM. Implemented and much Improved Quality metrics. Review and improve QMS, processes and practices across site. Recruited a high performing team. Developed a site strategy and introduced a strong positive Quality culture across the site. The Quality function has transformed and the site is now very successful and receiving considerable investment, awards and much increased customer satisfacton and employee engagement.

Toronto, Ontario, Ca

Responsible for the redesign, restructuring and transformation of the Corporate Audit function. Leading the Corporate Audit team through significant change from a centralised to decentralised function. Recruitment of new and highly talented audit teams globally. Establishment of an Auditor Training and Certification program. Embedding quality support and involvement across critical business functions.

Responsible for the leadership and direction of a global QA team, ensuring MA/CTA, GMP/GDP and CS compliance of Shire's global contract commercial and clinical manufacturing and distribution suppliers. Responsible for developing and embedding a culture of quality within the Global Supply Chain organisation. Initially forming a team of Quality professionals to create and embed an EU based quality team and ensure appropriate compliance systems put in place and executed against. Secondly to embrace globalisation of QA across Shire and and lead a global team to assure that all commercial and clinical outsourced manufacturing and distributon met all required quality and registered standards.

Starting up and embedding a local QA function with the implementation of corporate Quality initiatives. Interaction with global manufacturing, marketing, sales, medical and regulatroy functions. Responsible for the technical quality support of the product supply chain into the UK and RoI. Interacting with local and global manufacturing and distribution sites, and across multiple disciplines including medical, marketing, Sales and Regulatory.

Create and embed a new QA function. Full responsibility for assuring product quality and compliance. Provision of technical support in execution and completion of ISO 9002and TQM projects.

Managing the Analytical QC and Analytical Services laboratories.

Post Gaduate Diploma In Industrial Pharmaceutical Studies

Graduateship Of Royal Society Of Chemistry, Chemistry

Higher National Certificate, Chemistry

O And A Levels, Mathematics, English, Sciences, Languages, Geography, Statistics