Deloitte Development, LLC
Advisory Manager (Regulatory & Compliance)
Deloitte is one of the leading professional services organizations in the United States, specializing in audit, tax, consulting and financial advisory services with clients in more than 20 industries. We provide powerful business solutions to some of the world s most well-known and respected companies, including more than 75 percent of the Fortune 100.At Deloitte, you can have a rewarding career on every level. In addition to challenging and meaningful work, you ll have the chance to give back to your community, make a positive impact on the environment, participate in a range of diversity and inclusion initiatives, and find the support, coaching, and training it takes to advance your career. Our commitment to individual choice lets you customize aspects of your career path, your educational opportunities and your benefits. And our culture of innovation means your ideas on how to improve our business and your clients will be heard.Deloitte & Touche LLP seeks a Advisory Manager (Regulatory & Compliance) in Parsippany, NJ. Work You ll DoPerform regulatory and compliance services to validate computer system including risk assessments and pre- post implementation reviews of large software implementations. Design, Implement and deploy integrated programs for clients to monitor compliance risks using Corrective and Preventive Action (CAPA), Electronic Document Management Systems (EDMS), ERP, and Manufacturing Execution Systems (MES). Ensure that deliverables meet the compliance requirements under the FDA Regulations 21 Code of Federal Regulations (CFR) including (FDA 21 CFR Parts 210, 211, 820, Part 11, ISO, EU, etc.), International Conference on Harmonization (ICH), International Standards Organization (ISO), Medicines and Healthcare products Regulatory Agency (MHRA), Prescription Drug Marketing Act (PDMA). Develop control frameworks encompassing regulatory requirements, including privacy and Sarbanes Oxley and application security designs. Identify and evaluate complex business process and technology risks and evaluate/implement internal controls that mitigate the risks. Perform general computer controls review for technical audits on a variety of platforms. Play lead role in designated tasks of project team in gathering, organizing, and analyzing data. Lead and manage large teams responsible for security, controls, and privacy requirements for ERP implementations in various industries. Interact with client to drive day to day activities, highlight issues and concerns, suggest resolutions; and design, manage and report project matrices to highlight project overall status, budget and schedule. #LI-DNI RequirementsBachelor's (or higher) degree in Computer Science, Information Systems, Information Technology, Electrical Engineering, Mathematics, Decision Sciences, Risk Management or related field (willing to accept foreign education equivalent).5 years of experience performing computer systems validation.Experience must include 5 years of:Evaluating and validating the installation of ERP systems, including SAP and Oracle, to comply with compliance and regulatory requirements;Performing risk assessments of ERP systems to ensure regulatory compliance with the following: FDA 210, 820, and 211;Overseeing Software Development Lifecycle (SDLC) including computer system validation and associated technical documentation (SOP, IQ, OQ, PQ, TSR, VSR, SRD) for the Life Sciences industry;Utilizing testing applications, including HPALM and JIRA;Overseeing change management, configuration change review, and status reporting;Planning, monitoring, and reviewing the work of junior team members;Interacting with client and senior managers to discuss deliverables, project status, risks, and timelines; andLeading teams of 2-5 people.Must possess: CPA, CIA, CFA, CA, PMP, FRM, PRM, CPC, ERP, CMA, or CFE.Position requires approximately 85% travel. BenefitsAt Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits.Learn more about what working at Deloitte can mean for you. Deloitte s cultureOur positive and supportive culture encourages our people to do their best work every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer well-being programs and are continuously looking for new ways to maintain a culture where our people excel and lead healthy, happy lives. Learn more about Life at Deloitte. Corporate citizenshipDeloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships with our clients, our people and our communities. We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte s impact on the world. Recruiter tipsWe want job seekers exploring opportunities at Deloitte to feel prepared and confident. To help you with your interview, we suggest that you do your research: know some background about the organization and the business area you re applying to. We also suggest that you brush up on your behavioral and case interviewing skills and practice discussing your experience and job history with a family member, friend, or mentor.Check out recruiting tips from Deloitte professionals.
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Category: Accounting & Auditing
Deloitte Development, LLC
Website : http://www.deloitte.com
In the United States, Deloitte LLP and its subsidiaries have 57,000 professionals with a single focus: serving our clients and helping them solve their toughest problems. We work in four key business areas — audit, financial advisory, tax and consulting — but our real strength comes from combining the talents of those groups to address clients’ needs. Fortune and BusinessWeek consistently rank our organization among the best places to work, which is good news for our talent and our clients alike. When the best people tackle the most compelling challenges, everyone wins.