Stacey W

Clinical Quality Assurance - 0 Years of Experience


Clinical Quality Assurance


Chicago, IL

Education Level:


Will Relocate:



Executive Profile Summary I have for over 25 years acquired a vast knowledge in cGMP, Quality Management Systems, and Quality & Compliance in the areas of Pharmaceutical / Biotechnology / Biologics / Chemical Product Development / Quality Assurance & Control, and Food and Chemical Industries (which includes Food & Consumer Goods), (Industrial Retail & General Manufacturing ). My detail-oriented critical thinking creative-problem-solving ability enables me to make informed, responsible decisions and handle multiple priorities effectively. I possess strong written and oral communication skills and execute productivity in a self-direct or team environment. My diverse background and expertise in Pharmaceutical Laboratories, Aseptic Manufacturing, U.S. FDA pharmaceutical industry regulations and guidance's allow me to execute improvements in the following areas: quality systems, operations, manufacturing, laboratory processes and continuous process improvements. As an experienced manager I lead a team of approximately 35 salaried associates, including 3 Supervisors and 1 Quality Engineer for a 2-shift facility, with multiple production areas, as well as 2 support functions. I am an energetic and motivating leader with proven ability to effectively manage both personnel and projects. While in California I managed and implemented quality for the manufacturing of the Dapivirine Vaginal Ring silicon medical device for AIDS prevention (Dapivirine is a non-nucleoside reverse transcriptase inhibitor). I prepared scientific manuscripts, co-wrote, formatted and presented peer-reviewed scientific articles. As a Scientist I created and applied design and development standards and procedures. Assisted in the study of Particle Analysis for the ZMapp (ZMapp is an experimental biopharmaceutical drug comprising three chimeric monoclonal antibodies as a treatment for Ebola virus disease). In the lab I performed approved experiments, acquired and processed data, and compiled results and maintained compliance with all company and industry policies and procedures. "While in the food industry, " I supported new product tests, test markets, intermediate scale production, and product development for Mc Donald's and General Mills. Also, one of my hard skills is that I excel at analyzing products and procedures to generate new ideas to improve efficiency and production quality. I'm highly adaptable to ever-changing circumstances and play as a key role in any team. I also have the project management experience to help develop and execute strategic business plans. As a dedicated team member I maintain professional working relationships with executive management, associates, colleagues, scientific advisors, scientist, and clinicians. I am confident that my years of experience will meet any of your business needs and fulfill all requirements of the following certifications Certified Quality Auditor (CQA), Certified Quality engineer (CQE), Certified Manager of Quality and Organizational Excellence (CMQOE) and ISO 9001:2008 Lead Auditor Training Professional Profile Summary Experience Stacey Womack / GreyGapGlobal, LLC Professional Summary Experience cont. Quality Assurance Manager at NuSil Technology LLC (TRELYST) Familiarity with FDA regulations and guidance * Experience responding to FDA Information Requests and Complete Response Letters * Experience with oral dosage, transdermal, foam and semi-solid dosage forms * Experience providing regulatory assessments of post approval changes * Experience providing strategic regulatory advice in support of DMFs, INDs, NDAs, ANDAs, and BLAs * CMC and regulatory submission support, including NDAs, ANDAs, and INDs, FDA/regulatory agency preparedness * Expertise in applicable US and EU laws, regulations, guidance's, and best practices * Completed numerous gap analysis, audits and mock inspections * Pharmacovigilance training and education * Performed Quality oversight for single-site remediation * Executed multiple Gap analysis, audits and mock inspections * Ability to perform the following: Electronic data capture and data mining * Thorough knowledge of Quality systems and processes related to Pharmacovigilance * Experience in an aseptic pharmaceutical manufacturing firm


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