Our Value Proposition: Science & Technology, champ,Business and Technology Management with Operational Excellence and Continuous Improvement. Biologics (Vaccines, Cell & Gene Therapy, Therapeutic Proteins & Monoclonal Antibodies)/Medical Devices/Combination Products Strategic Senior Expert Consultants with Hands-On Experience with Operational Excellence in Process, Analytical, Formulation, Technology Transfer, Quality, Compliance and Regulatory • Strategic and operational management with lean cost-effective solutions • Bring integrated solid strong science and business management leadership tools and techniques for CMO and the Company • Project Management and Product Management • Take accountability and responsibility on your behalf • Transparent and confidential communication • Maintain highly professional ethics, integrity, intensity, and innovation • Providing company and CMO quality, QC Testing, and GMP manufacturing staff training on o Contamination Control (routine problem in biologics GMP manufacturing and QC Microbiology and Testing Laboratories) o Continuous improvement using Operational Excellence and Six Sigma Black belt methodology and training • Excellent senior strategic and tactical consulting team with multi-tasking, analytical, organizational and leadership skills. As a global expert in Vaccines Quality Management Systems, we offer oversight both Internal and CMO (external) Quality (QA-QC), Data Integrity & Reliability (ALCOA & ALCOA Plus), Compliance (audits, gap assessment, 483s, Warning Letter, and Consent Decree and proactive remediation and Regulatory (documentation, 3rd party FDA batch witness and batch release, review Annual Reports, Batch records, Validation Protocols, and Reports, Clinical Protocols and Reports and CMC and eBLA/eCTDs). Lean Six Sigma Continuous Improvements in process, MST, Analytical methods, Technical and Quality Operations. Regulatory Filings (IND/NDA/eBLA/eCTD). Biologics Site audits, gap assessment & remediation