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Quality Assurance Manager

3 months ago

Madison, United States PSG Global Solutions Careers Full time

Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Quality Assurance Manager, working in Pharmaceuticals and Medical Products industry in 5 Giralda Farms, Madison, New Jersey, United States. Job description:Provides independent quality support for global computer validation projects in the quality/regulatory area, such as TrackWise, under the guidance of the Global Quality Computer Compliance team.Reviews and provides input to validation and test strategies; verifies documentation in compliance with internal procedures and external regulations; communicates quality requirements across various departments, participates in review and approves requirements, test scripts, reports and other SDLC documentation with a focus on quality, and testability.Participates in process changes in the organization.Participates in audits.Participates in change management of additional systems. Our ClientOur client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models. Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.Experience Required for Your SuccessRequirements:Bachelors Degree in Engineering or SciencesMinimum of 5-8 years experience working in life sciences industry with focus in the area of Quality AssuranceExperience working with various GxP Enterprise Computerized Systems (on-premise and Cloud based (SaaS) COTS) used in the life sciences industryMust be well-versed with Software Development Life Cycle (SDLC) methodologies such as Waterfall and V-modelIn-depth knowledge of US FDA regulations, ISO standards, MHRA and EU regulations (including Annex 11), and ICH guidelines and Drug Development Life Cycle processExtensive experience developing and using risk based approaches for computer systems validationExperience in managing multiple projects and determined to get job done correctly and on timeKnowledge in TrackWise and Crystal Reports is a plusMicrosoft Office experience (Word, Excel, PowerPoint)Experience with Microsoft SharePoint is also recommendedGood organization skills and strong interpersonal skills as well as ability to work with other departmentsWhat Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?