Description
Career Summary * Accomplished and integrity-driven SME professional offering over 25 years of experience on the Pharmaceutical and Biotechnology/Medical Device business with success on national and international levels with comprehensive small and large scale management and engineering experience in diversified projects. * Strong background in Managing/Leading/Mentoring Capital Projects, cross-functional teams, program development and quality assurance with outstanding history of managing projects from initial conception, through development, to implementation. * Unexcelled record of bringing mission-critical projects in on schedule and within budget. Especially skilled at strategic planning, budget controls and daily problem/issues troubleshooting/resolution/team mentoring with sensible achievable solutions. Seasoned SME on developing strategies, planning, scheduling, contingencies and remediation. Regulatory and QA mission driven career. * Strong Project Management skills for New Facilities (Clean room designs, construction, implementation, maintenance and qualification), Capital Expense Projects, Installation, Commissioning, Qualification. GXP Work Plans, Consent Decree Work Plans, GAP Analysis, Site Remediation (Strong CAPA Projects Lead) of New and Legacy Facilities, Utilities and Processes. Product/Process Development/Sustainability and SME on all fields of Validation. * Outstanding communication skills with proven ability to build mentor, train and lead highly efficient teams. Seeking a leading position as a career employee or a contractor within a consulting firm or a Life Sciences company that will utilize all my skills and experience to robust their top quality management team.
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