Robyn Mclean Email & Phone Number

A Quality Management leader and a pragmatic professional with an open and communicative approach with the ability to develop teams as well as effective working relationships with stakeholders at all levels who enjoys being in a position with an international reach. Considered a flexible, persistent and resourceful Quality Management professional with a strategic mindset analyzing the quality and, operations processes from a systemic perspective with the ability to review business contractual documents, workflows, and SOPs – with the goal of identifying gaps and planning Continuous Improvement (CI) initiatives relating to quality, safety, and day-to-day operations. Proactive management style relying heavily on data-driven trends and analyses and a “system of engagement” that rallies around multidisciplinary teams to contribute to overall quality performance in an endless search of more efficient ways to keep up with ever-changing regulations.Subject Matter Expert (SME) in understanding Quality's role and significance to the GxP and Pharmacovigilance processesExcessive knowledge and application of global regulations and guidelines in relation to the medicinal products industryA proven leadership record and of track record working with Quality Assurance in an international pharma environmentExtensive experience in clinical trials, licensure and lifecycle management of products, and global GxP and inspectionsExperience with large stakeholder management and reporting to senior management teamsRobyn's management experiences is multidimensional and an integral part of the successes across all functional units.