Sharon McDonald's Linkedin Analytics

Specialties: Portfolio, Programme and Project Management HE Estates Portfolio Management Leading the establishment of digital portfolio management office, PMO at University of Nottingham. Pharmaceutical R&D programme & project management. Schedule and Budget management. Soft skills - facilitation of workshops, PPM scoping, planning and strategy. P3O Practitioner P3GP - P3 Governance Professional PRINCE2 Practitioner PhD Chemist PGCE Secondary Mathematics CIM Adv. Cert. Marketing 4 years experience in Higher Education Estates & Facilities Portfolio Management. Currently leading the development and digitalisation of the UoN Estates Portfolio Management Office. 20+ years working in pharmaceutical development & manufacture. I've managed programmes & projects across a wide scope of activities, some of which are listed below and all of which required up-front logistical problem solving and proactive planning & management of cross functional teams. Global packaging redesign, planning and implementation for licensed products Change control & process improvement Market-driven Regulatory requirements - planning for eCTD / NEES submissions, variations Supply chain, pharmaceutical process technologies - tech transfer / product, process and method validation Clinical trials / regulatory strategy for new product development, widening indication for improved claims Manufacture & packing of Clinical trial supplies Factory Scale-up and new product introduction Equipment validation - DQ, IQ, CQ, OQ, PQ ICH Stability chambers - commissioning & validation, sample relocation programs Information systems - planning & management of computer systems validation & UAT Working within regulated GMP / GCP environments. Risk management & scenario planning Cost & resource planning Experienced in development, validation & manufacture/packing of solid dose tablet & sachet products, medicinal liquids and creams, with working knowledge of medicated confectionary and soft gel capsules.