Unanticipated risks have great consequences for clients. That’s especially true today as new risks and complexities brought on by regulatory mandates, rapidly evolving technologies, and the digitalization of business operations are disrupting traditional business models. Deloitte Risk and Financial Advisory’s Hybrid-Operate teams deliver next-generation managed services and advanced technology products to help organizations solve complex problems on a long-term basis. Teams do this by bringing together advanced analytics, robust domain knowledge and experience, and strong technology products to help clients monitor, manage, and measure their operational environment for risk.

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.

Work you’ll do:

• Ensures documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies.
• Review functional or technical requirement documents and develop test cases to the stated requirements including positive and negative testing.
• Review the accuracy and completeness of software validation deliverables created by other process teams (e.g., Requirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)
• Create Traceability Matrices linking approved requirements to test cases in HPQC (both automated and manual).
• Works with fellow validation and project team members in a dynamic environment with shuffling priorities and responsibilities.
• Provide expertise in the review of all deliverables across the project lifecycle, ranging from requirements documentation to final protocol reports.
• Keeps the validation lead informed of any issues regarding the quality of the deliverables, or any potential sources of impact to the project timeline.
• Accurately report the status of assigned deliverables and support other compliance work as necessary

Prior experience with the following:

• 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
• Desiging, implementing, and navigating waterfall and agile SDLC (System Development Life Cycle)
• SAP/ERP Validation and test management
• Leading IT risk, IT quality and IT compliance transformational programs
• Executing Change Control, and Document management
• IT Quality Management Systems and CAPA management systems
• Designing IT risk, IT quality and IT compliance operating models
• Designing and implementing IT quality and compliance life sciences controls for cloud products
• General IT strategy experience

The successful Senior Consultant will demonstrate the following attributes:

• 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

Required Qualifications:

• 4+ years working in the Life Sciences Industry
• Experience with MS Office applications including Word, Excel, PowerPoint, and Teams
• Knowledge of IT systems, applications and tools required
• Knowledge of process excellence (Six Sigma, LEAN, Design Excellence), certifications preferred

Preferred Qualifications:

• Experience in the validation of software tools in an FDA regulated environment. (e.g., SAP, SAP Solution Manager, and HPQC.)
• Knowledge of regulations and software lifecycle approaches 21 CFR Part 11 and, QSR’s, ISO 13485, 21 CFR part 11,820,807,803 GAMP, SDLC methodologies)
• Experience in development of Validation Master Plans for simple systems or facilities.
• Experience in Project execution within at least one area of systems validation – e.g., laboratory equipment, facilities, utilities, manufacturing equipment, metrology equipment, information systems.

The team

Deloitte Risk and Financial Advisory’s comprehensive Digital Quality & Compliance solution provides global life sciences clients with a cost-effective, risk-intelligent approach to Digital Quality & Compliance empowered with speed and agility - from strategy and implementation to management. Leveraging Deloitte’s distinct Hybrid-Operate delivery model, our Digital Quality & Compliance solution brings together a holistic alignment of the best people, processes and a technology-enabled platform to help our clients modernize IT business, boost performance, and accelerate adoption and deployment throughout the entire software development life cycle (SDLC).