Doug Weber Email & Phone Number

A flexible and strategically focused quality and business professional with over 30 years hands-on management experience in the biopharmaceutical industry with specific hands-on practical experience and knowledge in the respective biotechnology and drug pharmaceutical sectors. Principle strengths include developing a strong business function which is committed to ensuring compliance to the organization’s business objectives and governmental regulations, including auditing, assessing, implementing and managing quality and regulatory business methods, systems, and tools in organizations. Strong problem-solving and communication skills, the ability to concisely analyze and determine strategic issues. High energy and drive and the ability to work effectively with others, with expertise in the following disciplines:• QA/QC/RA business, operations & strategic planning for multi-sight operations.• Drug formulation, pre-clinical, early Phase 1/2 development, testing, scale-up and validation.• cGLP, cGMP and USDA regulated facility design, construction and validation.• Quality & regulatory compliance audits and inspections (including Canada, Western Europe and Puerto Rico).• Analytical and microbiological laboratories, manufacturing and operations management.• New method process scale-up, qualification, technology transfer and commercialization.• Review and/or approve SOPs, validation protocols, change control, labeling, etc.• Contract production for aseptic filling, small volume parenterals and lyophilized products.• Change control and risk mitigation, CAPA based analytical processes and methods.• Documentation control system design and SOP development histories.• Multiple sight training, development and succession programs.Specialties: Proven record of accomplishment in developing and implementing strategic solutions, achieving high standards in quality assurance and control. Expertise in compliance risk management, process management, documentation, and global regulatory agencies, including International Committee on Harmonization, ICH. Reengineered production processes, eliminating costly product deficiencies and improving customer satisfaction.