Heather Hill Email & Phone Number

Columbia, Maryland, United States

Integrated the Smith + Nephew total quality management system into the Columbia, MD quality system, resulting in one quality system that was compliant and manageable for both medical devices and human tissue products. Transferred the regulatory activities to the Fort Worth Regulatory team allowing for a uniform regulatory review of products within the wound care portfolio.Implemented site metrics aligning with corporate quality metrics which reduced complaint and out of specification investigation review times from > 365 days on average to 60 days on average and CAPA items completed from 10% to 100% completed on time.

Columbia, Maryland, United States

Coordinated and implemented the due diligence for the operational and quality transactions for the Osiris acquisition activities, supported and negotiated transactional terms which resulted in Osiris to be acquired by Smith + Nephew Consolidated, Inc.As part of the site leadership team, performed strategic planning of new product and existing product development which supported the growth of the company to 100M+. As tissue bank director, was responsible for the implementation of the policies and procedures of the board of directors, maintaining the total quality system, implementing change management, and doubling the quality team. Led regulatory audits which resulted in zero 483's or finding from the FDA, and AATB and state reaccreditation and licensure.

Led quality improvement initiatives and collaborated with FDA and other industry leaders to maintain compliance for human tissue products. Led the follow-up FDA audit which resulted in zero 483's and no regulatory findings. Implemented a promotional material review system to ensure future marketing materials remained in compliance.Implemented the quality and regulatory strategy, evaluated and processed quality documentation, and reviewed clinical protocols to support the launch of 2 new products. Implemented continuous improvement strategies to ensure customer satisfaction and resolution of complaint investigations.Transferred three products to two contract manufacturers to allow 150% additional manufacturing capacity. Developed and maintained the quality system for contract manufacturer oversight in addition the the corporate procedures.

Developed and implemented a strategy to close out the 2013 Untitled Letter from 2013, including engaging ombudsman to get FDA to issue a resolution letter. Implemented the regulatory strategy for world's first approved stem cell drug, Prochyma-L)l (remestemcel, in Canada and New Zealand. Wrote and submitted the CMC and drug regulatory filings in US, Canada, Switzerland, New Zealand, and Australia.Led cross-functional teams to implement the quality systems to support both human biologic drugs and human tissue products. Worked with the site leaders to launch and commercialize four human tissue products.

Osiris, Therapeutics

Responsible for writing and compiling information for five IND's and the CMC sections for the Type II and Type V master files.

Columbia, Md

Implemented and maintained the GMP and tissue based quality systems. Ensured the timely turnaround for lot release, acted as lead on audits, performing internal and external supplier audits. Review and approved the quality documentation and transferred the quality control laboratory from Baltimore, MD to Columbia, MD.

Columbia, Md

Led EU inspection of quality control laboratory resulting in approval in Quality Person (QP) and clinical trials in Europe. Built and developed the quality control teams. Implemented assay validation program for ELISA's, flow cytometry, and USP methodologies. Implemented stability programs to support the shelf-life of Phase I, II, and III clinical products.