Principal, Quality Center of Excellence
Building on 40 years of industry and leadership experience, Jane brings a wide range of Quality & Compliance experience to YourEncore, tailoring Quality Management Systems aligning with ICH E6 (R2) and other regulations, developing strategies for weaving the business and R&D quality together, consulting on R&D quality and compliance issues. Jane specializes in helping prepare for, mitigate, and resolve global Regulatory actions, including mock inspections, assessments and audits.
Core competencies include: GxP Compliance Advisor, Quality Management Systems, Health Authority Inspection Readiness and Remediation
Jane most recently led the R&D Quality & Compliance function for Johnson & Johnson, leading a global team of 360 colleagues with broad-based GXP compliance responsibilities across the Pharmaceutical, Medical Device, and Consumer sectors.
Jane began her career in the UK in the Blood Transfusion Service as a GMP Production Manager and then progressed to head up Quality in a Scottish CRO. During her tenure at the CRO, Jane assumed leadership across all the GXP QA functions including IT, Animal Health, GMP, GLP, GCP, and ISO 9001. Following these broad-based career experiences in the Quality arena, Jane moved to Italy to gain International experience. During the next several years, along with a succession of mergers and acquisitions, Jane headed up diverse and increasingly large global Quality and Compliance functions including Pfizer and Johnson & Johnson.