With over 14 years of biotechnology experience as an IT professional with experience supporting and maintaining multi-tier applications. Skilled in requirements analysis, documentation, troubleshooting, and resolving system issues. Experienced in software implementation, system enhancements, and defect resolution. Focused on improving IT operations through effective support and process optimization. Also certified in OCI - Generative AI and OCI - AI Foundations.More...
Rosa Silva
NA
Verified
Extensive pharma/biotech experience including Leadership, Field Reimbursement, Payer Account Management and Sales. Cardiology, immunology, neurology, oncology and rare disease launch experience for biotech startups. Expertise in medical and pharmacy coverage, coding, and payment across all public and private payers (Commercial, Medicare FFS, Medicare Advantage, Medicaid FFS, Managed Medicaid, VA/DOD). Extensive knowledge of specialty pharmacy networks, integrated delivery systems (IDNs), buy-and-bill model, alternate sites of care (ASOCs), claims processing and product acquisition.More...
Danyelle Barber
Project management
Verified
I have worked in different areas of the biotech/pharma industry for the past six years, and during that time, in addition to growing professionally through professional certifications, I also developed a sincere love and interest for project management as a career and skill. My commitment to developing my skills and ambition have been proven by my work experience and genuine interestMore...
Helen Wilfehrt
Consulting
Verified
Educator, communicator, writer, and editor with strong quantitative and verbal skills.More...
Michael Delitala is an accomplished Quality Management Systems Process Owner with extensive experience in the biotechnology industry. He possesses a strong track record in Inspection Readiness and Participation, Root Cause Analysis, Deviation Management, Corrective and Preventive Action (CAPA) Management, and Technical Writing. Michael is recognized for his detail-oriented approach, effective communication skills, and ability to collaborate cross-functionally. His professional competencies also include Deviation Trending and Training, showcasing his commitment to maintaining high-quality standards and ensuring compliance in complex environments.
In 2024, Michael founded Delitala Quality Consulting & Author Corporation, where he serves as Chief Executive Officer. He is also a published author of seven works, contributing to the knowledge base within the quality management domain. Prior to his current role, he held the position of Associate Director of Quality Systems & Compliance at Avidity Biosciences, Inc., where he was integral to advancing the company's mission to revolutionize RNA therapeutics, emphasizing the importance of tissue selectivity and precision in therapeutic development.
From 2021 to 2023, Michael served as the Global Head of Training & Quality Risk Management at Kite Pharma. In this role, he oversaw global programs for Personnel Qualification & Training, implementing a comprehensive quality management system. His leadership was crucial in the successful rollout of multiple phases of the Next Generation Quality Management System, ensuring that all regulatory requirements were met while enhancing the overall customer experience.
Earlier in his career, Michael was a Senior Manager of Quality & Compliance at Amgen, where he played a key role in developing an AI-driven tool for deviation trending that won the 2018 Quality Innovation Awards.More...