An accomplished Quality Management and Regulatory professional and a Biochemist, with over 20 years of experience in a leadership capacity within the bio-pharmaceutical and clinical labs sectors. As a Consultant in a Regulatory consulting firm, I have assisted life sciences and medical devices companies in achieving their goals.As the Quality Manager of a laboratory in a hospital and a Laboratory Manager in a bio-pharmaceutical company regulated by the FDA, I have managed laboratory operations while implementing quality assurance and quality control programs, development of analytical methods and engaging staff, leading to significant performance improvement.KEY CAREER HIGHLIGHTS♦ Created a 2-day course on the regulatory of medical devices in Canada in comparison to other jurisdictions, presented and trained at corporation and academy settings.♦ Established a Quality Management System in the clinical lab from inception to execution within 2.5 years, and led the lab to successful accreditation in compliance with international standards.♦ Developed and managed the entire laboratory quality assurance and quality control programs. ♦ Established Corrective and Preventive Action (CAPA) and OOS investigation programs. ♦ Developed an electronic controlled documents database and maintained it current.♦ Authored, designed and approved SOPs for tests, validation protocols and reports in compliance with GLP/GMP and regulatory requirements. Being a seasoned manager holding a graduate degree in Biochemistry and a Quality Auditor Certificate from ASQ, I possess strong problem-solving skills and excellent decision-making capabilities. I have demonstrated outstanding abilities to transfer my skillset, as well as to acquire new skills at a very short time frame.My proven success of leading large projects with the ability to balance meticulous attention to quality and detail, always resulted in getting the job done on-time.AREAS OF EXPERTISE✔ Quality Management✔ Regulatory Affairs✔ Bio-pharmaceutical Industry✔ Quality Auditing✔ Project Management ✔ Laboratory Management