AERS - Life Sciences Technology Senior Consultant

Deloitte & Touche LLP's ("Deloitte & Touche's") Technology Risk ("TR") service area is comprised of professionals with a broad range of information technology and management consulting skills in the areas of Risk and Compliance, Security and Privacy, and Capital Markets. These professionals perform assessments, remediation, implementation and integration of end-to-end solutions in these three areas.  They also deliver advisory services focused on risk and compliance to IT management and senior executives for both external audit and internal audit clients.  TR professionals focus on information systems and technology that manage risk and/or drive operational, financial and regulatory compliance processes; as well as solutions that manage the risk associated with information technology itself. We are looking for a Senior Consultant for our Life Sciences practice based in our Parsippany NJ, WFC NY, or Philadelphia office:
Requirements:
- BA/BBA/BS in Information Systems, Computer Science,
Engineering or Science related field required
- MBA/MS/MA degree is a plus
- ASQ, PMP, Six-Sigma, or other similar certifications preferred
- 6+ years Life Sciences industry, vendor or consulting experience required
- Experience with Computer Systems Validation, Business Analysis, Regulatory Affairs, Quality Assurance within the Pharmaceutical, Biotech and/or Medical Device companies.
- Experience using, implementing and validating systems such as: corrective/preventative action (CAPA), complaint handling, laboratory information, enterprise resource planning, manufacturing execution, document management and e-pedigree systems, plus familiarity with a project management framework
- Knowledge of federal and international GMP regulations (FDA 21 CFR Parts 210, 211, 820, Part 11, ISO, EU, etc.) 
- Proficiency in MS office products, including Excel, Word and PowerPoint is required
- Strong verbal and written communication skills
- Strong technical
and organization skills
- Analytical and detail oriented
- Team oriented
- Ability and willingness to travel 75%
Responsibilities include:
- Provide engagement or task management and select appropriate methodologies
- Play substantive role in client relationship and communication
- Play substantive role in attaining quality internal and external communication deliverables including technical content of reports, proposals, etc.
- Demonstrate high level of understanding of client's business
- Demonstrate strong knowledge industry or functional specialty
- Play substantive  role in engagement planning, economics, and billing
- Deliver services that meet Deloitte & Touche's engagement leader specifications
- Participate in professional & civic organizations
- Produce material for internal publications


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