Description
SUMMARY Over 25 years experience in healthcare environments more than 20 years in the pharmaceutical industry, focusing on solids, semi-solids, liquids, and gels and 7 years in biotechnology (small molecule) and API, including roles in Regulatory Compliance, Quality Management, Quality Assurance and Quality Control (QM/QA/QC) using cGMP, GLP, GCP, ICH and ISO regulations and standards. * Regarded as an expert on Quality Compliance (FDA, CBER, CDER) * Alignment of compliance and business development contractual segments * Development of new business opportunities by performing due diligent audits and assessments * Development and implementation of systems such as Global Technology Transfer System that was created and developed for Business Development purposes that helped promote successful contract business initiatives which resulted in increase in sales * Takes a teamwork/matrix approach to leadership which includes incorporating the need to map processes and establishing realistic timelines with the team * Emphasis on continuous improvement/cost of quality * Strong analytical/problem solving skills * Reviewed and approved numerous manufacturing and analytical records * Identified limitations in the batch record review processes and developed checklists with CMOs to streamline effort and reduce turnaround time Speaker on variety of topics including: Annual Product Reviews, Technology Transfers, Supplier Qualification Programs, Setting Requirements for IQ/OQ/PQ/DQ. Attended a variety of seminars, including: Disease Control, QA, scale-up, IQ/OQ/PQ, cleaning validation, process validation, GMP, adverse events, specification generation, Quality Compliance, Part 11 Requirements, electronic signatures in the pharmaceutical Industry, auditing, regulatory requirements for CMC/IND/NDA/ANDAs. Certified Lean Six Sigma.
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