Validation Compliance Analyst (GIS)
Illumina, Inc. - San Diego, CA

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Accountability Summary The Global Information Services (GIS) Senior Software Quality Analyst supports Illumina’s GIS Leadership Team in optimizing IS quality and compliance practices to costeffectively meet strategic operational and legalregulatory objectives The Analyst leads activities that result in risk reduction maturity of IS quality practices operational efficiency procedural compliance and actionable performance measurement – all with the intent of deceasing quality costs and increasing profitability This position interacts with all tiers of staff and management up to the executive level and must possess effective business acumen Specific Accountabilities 1 Acts as agent of change and innovatively transforms the IS Quality culture 2 Drives the IS quality maturity roadmap 3 Develops and maintains scalable IS quality methodologies frameworks and procedures 4 Defines IS validation and qualification roadmaps and plans 5 Manages system validation projects and vendors writesexecutes test plans as needed 6 Executes IS risk assessments and audits 7 Ensures corrective and preventive actions are completed as planned 8 Reduces the riskadjusted cost of qualitycompliance 9 Measures performance against key quality metrics as defined by the GIS Leadership Team 10 Provides guidance on emerging quality and regulatory compliance matters Skills and Technical Knowledge 1 Ability to think like an entrepreneur focused on increasing profit through IS quality management 2 Strong working knowledge of relevant quality regulations and frameworks – eg CFR 21 Part 82011 ISO 13485 ISO 9001 CobIT 41 ITILv3 GAMP 3 Advanced experience conducting risk assessments and performing process andor software quality assurance activities for a larger enterprise 4 Superior communication and problemsolving skills ability to identify root causes and propose effective practical solutions that deliver measurable business value 5 Excellent process analysis and redesign skills 6 Strong project and vendor management experience 7 Solid business process and information architecture knowledge 8 High level of energy and commitment to driving a vision from concept to implemented solution ExperienceEducationCertification 1 Minimum 3 years of experience in performingleading IS risk assessments and audits 2 Minimum 3 years of progressive responsibility in IS quality 3 Bachelor’s degree in technology business or lifesciences discipline master’s degree desirable 4 Experience with innovative medical device or biotechnology company preferred Equal Opportunity EmployerAffirmative Action Employer system testing, validation, ISO
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Illumina elucidates the human genome. The firm makes tools used by life sciences and drug researchers to isolate and analyze...