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Sr. Consultant-Regulatory and Legal Support-Corporate C

Deloitte

This is a Full-time position in Parsippany, NJ posted July 22, 2021.

Deloitte Advisory helps organizations turn critical and complex business issues into opportunities for growth, resilience and long-term advantage. Our market-leading teams help clients manage strategic, financial, operational, technological, and regulatory risk to maximize enterprise value, while our experience in mergers and acquisitions, fraud, litigation, and reorganizations helps clients move forward with confidence. We help clients create and protect value in order to realize strategic objectives, protect shareholder value, and achieve improved profitability. We help organizations anticipate the changing regulatory landscape enhance the Internal Audit function for greater performance and value and navigate and resolve business crises, controversy, and transactions to mitigate disruptions. From new and emerging regulation to global corruption and corporate fraud, our highly skilled specialists leverage advanced, technology-enabled solutions to help clients more confidently make decisions to drive performance. We are looking for a Life Sciences Digital Quality and Compliance Senior Consultant, who has Experience in Life Sciences Industry, SAPERP Validation, functional knowledge of Pharmaceuticals, Biologics, Medical Devices Diagnostics and FDA regulations, knowledge of analytics and reporting tools, strong communication skills, proficiency in MS Office suite. Key responsibilities are as follows Experience designing, implementing and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management Experience designing, implementing and navigating waterfall and agile SDLC (System Development Life Cycle) Experience in SAPERP Validation and test management Experience leading IT risk, IT quality and IT compliance transformational programs Experience in executing Change Control, and Document management Experience with IT Quality Management Systems and CAPA management systems Experience designing IT risk, IT quality and IT compliance operating models Experience designing and implementing IT quality and compliance life sciences controls for cloud products General IT strategy experience Knowledge of IT systems, applications and tools required Knowledge of process excellence (Six Sigma, LEAN, Design Excellence), certifications preferred Qualifications – External 4+ years working in the Life Sciences Industry IT Risk, IT Quality and Compliance Management Extensive knowledge of system development life cycle controls Demonstrates a service-oriented leadership style Knowledge of lean and risk-based process and service attributes Broad-based knowledge of industry leading practices for IT risk and compliance Demonstrates an executive presence through good communication and professionalism Exposure to cross functional teams (lead, co-ordination),ability to deal with all employees and external business contacts while conveying a positive, service oriented attitude Attention to detail, quality, time management and customer focus Interpersonal and ability to operate effectively in a matrix environment Experience with MS Office applications including Word, Excel, PowerPoint