Michael Stevenson Email & Phone Number

United Kingdom

• Provide strategic governance of Global Quality Training as head of the Group-wide Quality Training Team and Business Process Owner for the SuccessFactors Learning Management System (LMS) for 30,000 global users. My key.
• Maintain the regulatory compliance of Global Quality Training policies, procedures, and business processes.
• Lead a global team of instructional designers and LMS specialists, advising Quality leadership, LMS administrators, and Qualified… Show more Provide strategic governance of Global Quality Training as head of the.
• Lead a global team of instructional designers and LMS specialists, advising Quality leadership, LMS administrators, and Qualified Trainers on global training policy, guiding primary system owners and SMEs on the.
• Establish the Quality Management processes for new digital training technologies, modernizing approached to actively engage with new employees and retain best talent through user-centred learning.
• Lead the group-wide Qualified Trainer program, providing strategic and technical guidance for standardization of global training development, delivery and assess-ment practices.

United Kingdom

Provided Director-level support in addition to Senior Manager role.

Groningen, Netherlands

• Management of GxP training processes during successful commercialization and Licensing of a Biologics facility by FDA, ANVISA, Health Canada, and IGJ Authorities.
• Managed and maintained site training program, procedures, and electronic Learning Management System in collaboration with Site Leadership for approximately 200 staff.
• Managed SME inspection coaching in successful FDA, ANVISA, Health Canada, and IGJ PAIs & authored effective responses to regulatory… Show more Management of GxP training processes during successful commercialization.
• Managed SME inspection coaching in successful FDA, ANVISA, Health Canada, and IGJ PAIs & authored effective responses to regulatory observations.
• Implemented the site’s first Train the Trainer qualification and SME certification process, coached and mentored newly Qualified Trainers.
• Coordinated local activities for a global electronic Learning Management System implementation.

Reykjavik, Iceland

Implementation of a GxP training system for a startup biosimilars development and manufacturing facility, I played a fundamental role in the establishment of a GxP/Quality culture within a new facility that has since been successfully awarded an EMA GMP certificate.Process Development:-Process owner for GxP training within the Quality Management.

Slough, United Kingdom

Responsible for the design, execution, and evaluation of training within a biologics R&D facility-Implemented competency-based training processes-Developed new starter induction programme-Generated materials and conducted training for GMP processes-Wrote and delivered Scientific & Technical training materials-Responsible for training aspects of local.

J&J Depuy Synthes, Leeds

Assisting companies in remediation or maintenance of GXP, regulatory and corporate standards, with particular emphasis on Quality Systems, Electronic Systems, Change Management and Training.

Liverpool, United Kingdom

Responsible for design, execution and evaluation of training within the QC department of a GMP manufacturing facility:-Implemented a new QC training procedure which was adopted globally across the division-Implemented a site-wide electronic Learning Management System, including development and delivery of end user training to employees.-Contributed to the.

Liverpool, United Kingdom

Seconded as SME for ICH Stability programme, ensuring control, escalation and governance of stability issues to Senior Management: --Designed and co-ordinated stability protocols/reports for products manufactured on site or by CMO-Provided guidance for new product introduction and development-Initiated meetings with Senior QA, Regulatory and Technical.

Liverpool, United Kingdom

Conducted a broad range of varied and complex training activities, to support a number of teams directly within QC. -Designed and delivered specific training programmes across the site, as required by the internal training curriculum-Mentored recruits and staff members undergoing role change and development-Managed the NVQ Quality management systems for.

Liverpool, United Kingdom

Seconded as a member of a project team implementing a CFR 21, part 11-compliant LIMS for the entire manufacturing facility. Project implementation significantly contributed to approval by the FDA and the successful return to market of the manufacturing facility after a period of remediation: --Participated in system design /process mapping and generation.

Liverpool, United Kingdom

As a member of Virology team performed QC testing of in-process and finished vaccine products-Conducted ELISA, SDS-PAGE, Single Radial Immuno-Diffusion [SRID], Mircotitre Haemagglutination and Haemagglutination Inhibition assays -Conducted Technical Studies and Performance Qualifications-Conducted Flu clinical trial sample analysis as a member of the GLP.

Port Sunlight, UK

As a member of the Dental Research Department, performing laboratory-based research to determine efficacy of oral care products and potential candidate materials.