Sr. Consultant-Regulatory and Legal Support-Corporate Compliance & Operational Risk
Location: Parsippany, New Jersey
Internal Number: 15335298
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, SAP/ERP 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 SAP/ERP 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
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