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Executive Leadership and Commercial Operations: Life Sciences Industry
Expert possesses over 20 years of experience in Pharmaceutical Commercial Operation. He has held progressively increasing responsibilities, at big pharma, mid-size and small pharma. His extensive leadership history includes 7 years at Regeneron Pharmaceuticals as Senior Director of Commercial Operations.…
Food, Cannabis, Quality, Compliance, Edibles, Manufacturing, Processing and Operations
US Navy veteran who found a place in food and regulatory compliance after serving active duty. Experienced in baking, dairy, beverage, confections, chocolates in the food sector for over ten (10) years. While pursuing an MBA (graduated in 2019) pivoted…
Digital Transformation; Operations, Risk, Compliance, Internal Audit
Versatile multi-industry risk and operational executive with demonstrated record of success, consistently finding creative solutions to address complex and challenging problems, influencing others, building high-performing teams, developing talent and collaborating for results. Experienced in digital innovation and transformation, organizational behavior,…
Senior Safety
Over 40 years experience in various facets of safety and mechanical engineering, including over 30 years experience addressing commercial nuclear power and/or Department of Energy (DOE) facility programs. Expert has served as Senior Worker Safety and Nuclear Safety Advisor for…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Engineering, Oil and Gas, Business Development
Expert has 25 years plus experience with Oil and Gas Management including: - Service and equipment analysis - Onshore Shale FRAC Sand Water - West Texas Permian Basin Subject Mater Expert - Pipeline Operations and Marketing Subject Mater Expert -…
Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing…
Strategy Development and Implementation; Operations; Organization Change; Higher Education; Leadership/Development; Culture Change
Expert is a renowned leader and pioneer in strategic management systems and leadership, and one of a select group with executive leadership experience in academe, nonprofits, government, and business. Over the course of his career, his change initiatives and counsel…
Near Infrared Spectroscopy, Multivariate Analysis, Pharmaceutical Analysis, (GMP)
Expert is an internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods, including near-infrared and multivariate analysis. Nineteen years of industry experience with increasing responsibility and five years of policy…