Job Description Position Director of IT (RD) for Pharma Duration Full Time Location Los Angeles CA Required Skills FDA 21 CFR Part 11 and HIPAA Description Bachelorrsquos degree in Computer Science or related field and 10+ yearsrsquo work experience in deploying and supporting RD systems with 5+ years or experience managing people and external vendors for project and support delivery. Direct experience in software deployment, development andor programming design and systems management in an FDA Regulated Environment Proven experience in overseeing the direction, development, and implementation of software solutions and deployment of 3rdparty hosted solutions. Expertise in system and software quality assurance best practices and methodologies Demonstrated capabilities with change management, corrective actionpreventive action plans, and IT Management systems Good project management skills andor substantial exposure to project-based work structures, project lifecycle models, etc Knowledge of database design, data catalog and elements to help deploy enterprise data capabilities. Strong understanding of basic system engineering, object-oriented design, information risk and security guidelines, and architecture standards Knowledge of applicable regulatory requirements, data privacy practices and laws including FDA 21 CFR Part 11 and HIPAA Proficiency in computer systems validation, including authoring IQPQOQ documents Strong understanding of Regulatory Affairs, Medical Affairs, Clinical Development, Health Economics and other RD functions Proficient with working with stakeholders across IT and RD business units. Deep understanding of RD business and translating that to IT solutions to help deliver value for RD Strong understanding of RD Data needs to optimize IT solutions. Strong customer-service orientation Excellent written and oral communication skills Excellent listening and interpersonal skills Ability to communicate ideas in both technical and user-friendly language. Ability to conduct research into application issues and products. Highly self-motivated and directed. Keen attention to detail Able to prioritize and execute tasks in a high-pressure environment. Experience working in a team-oriented, collaborative environment. An innovative, data-driven person with a ldquocan dordquo attitude and willingness to do the work. High bar personal ethics with a ldquopatients firstrdquo value system Role model for client TRAIT values (Transparency, Respect, Accountability, Integrity, Trust) Mrinal Jha Apolis 222 N Sepulveda Blvd., Suite 2250 El Segundo, CA 90245 Cell Email Mrinal.Jha(at)apolisrises(Dot)com httpMrinal.Jha(at)apolisrises(Dot)com Website www.apolisrises.com httpwww.apolisrises.com About Apolis Apolis. is an ERP and IT consulting services provider focused on providing innovative and successful business solutions. We are capable of working across all technology platforms, operating systems and infrastructures. Apolis has experience in performing implementations, technical and functional upgrades, optimization projects, and full-service staffing. ldquoApolis is an Equal Opportunity Employerrdquo and ldquos all those who are authorized to work in the US are encouraged to apply.rdquo Want to read more about Apolis Click here httpwww.rjtcompuquest.com to visit our website or click on following link httprjtcompuquest.comcategorypress-release . Connect with Apolis through Social Media Learn more about our company including latest events at RJT Compuquest, new job opportunities, jobseeker tips and more. Follow us on LinkedIn, Facebook etc.