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Complaints Handling System Analyst in San Francisco Bay Area at APEX Systems

Date Posted: 6/14/2019

Job Snapshot

Job Description

Job #:  970158
Our client is a leader in the pharmaceutical and medical device industry. They are one of the most recognized international companies in the world and they are seeking top notch talent to join their team.

JOB DESCRIPTION:


Responsible for working closely with Quality and Regulatory business partners to develop and maintain comprehensive Quality and Regulatory IT Road Maps.  Serve as the liaison between Quality and Regulatory business partners and shared services delivery teams to ensure that business needs and requirements are being addressed across Plan, Build, and Run areas.  Responsible for IT Capital and Expense financial projections, planning, and oversight for Quality and Regulatory systems.  Responsible for identifying technology solutions to meet evolving Quality and Regulatory business needs.
Responsible for building and maintaining expertise on the IT portfolio for the Quality and Regulatory function for Abbott Diabetes Care globally. Proactively analyzes business processes; elicits, analyzes, and documents business requirements; identifies alternative solutions, assesses feasibility and makes recommendations typically seeking to exploit and leverage new or existing IT technology components.
This role is also responsible for compliance with applicable Corporate and Divisional Policies and procedures. Understands and contributes to the business unit strategy, based on the specific business and technology expertise, and translates business strategy in aligned IT solution proposals. Constant awareness of evolving regulatory requirements and technology developments for the specific business process and influence the IT stakeholders and vendors in addressing these evolutions in the most efficient way. Understands the specific business processes in scope of the area of business and technology expertise, and make sure that IT solutions meet the needs of the processes. Consulting toward business process owners on tools and solutions based on own area of IT expertise.
This role also recommends solutions assuring fit with BU direction, strategy and priorities.
Closely collaborate with other disciplines like corporate IT, Engineering, and business process owners in the BU. Perform or aid in the analysis, requirements specification, design, and implementation of systems and programs for the area of expertise. Influence and partner with business leaders (Manager, Director) to manage and align the process specific IT portfolio.
Close collaborate with other parts of BU IT, Global Information Services, adjacent business departments and external partners to ensure adequate and timely delivery of agreed services, in line with agreed service levels. Partner and collaborate with key IT staff in order to support cross divisional business initiatives, and explore IT synergies and efficiencies.
Agrees with business process management, and Functional BRM on the projects and applications, and provides correct information for the business unit long range plan and budget. In the functional BRM team align the projects, identify conflicts and synergies, and act upon this. Oversee and control project capital/RCE expenditures and ROI. Continually look for opportunities for cost reductions and cost avoidance. Manage IT projects in own area of expertise, but up to division wide if needed, or participate in business projects based on IT expertise. Lead project teams responsible for selection of technology strategy for specific business unit.
Responsible for compliance with applicable Corporate and Divisional policies and procedures. Responsible for assessing the compliance of system solutions with regulatory requirements, inclusive of validation. Operates with goals set by the Functional BRM. Erroneous decisions would normally result in failure to complete projects critical to major objectives of the business unit.
Has direct impact on capital budget, expenses and major project completion. Accountable for the accuracy of the fit of the proposed business process improvements and the technical solution to the business needs and the information upon which the business justification and prioritization decisions are made.
Also accountable for communicating the business need and drivers to development groups to assure the implementation phase can fulfill the business need.
Financial implications of the applications ranging up to $ 5 MM. Cumulative project budgets ranging up to $3 MM. 500-2,000 users and $1-5 MM.
Minimum Qualifications:
  • Bachelors Degree in computer science, engineering, business administration or another discipline relevant to the role.

Preferred Qualifications:
  • 5-8 years of IT experience in large or mid-sized multinational healthcare organization.
  • IT expertise in FDA Regulated Quality Systems and associated business process. Deep knowledge on IT technologies and products used in Quality Systems including Complaint Handling, 21 CFR Part 11 Compliance, HIPAA/PHI, HL7, PLM, Doc Management, and e-submissions. 
  • Experience with complaint handling processes or complaints handling systems.
  • Ideally, experience with Quality Systems in the medical device industry. 
  • Familiar with process and data flow mapping for Quality Processes. 
  • Familiarity with global GxP regulations applicable to IT. 
  • Familiar with FMEA and FTA processes, ideally for medical devices. 
  • Experience with GxP SDLC methodologies including Agile and Waterfall. 
  • Experience with software validation. Experience working effectively in a shared services IT model.

 
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EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.