Senior Information Systems Auditor
Illumina - San Diego, CA

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Accountability Summary

The Global Information Services (GIS) Senior Quality Analyst supports Illumina’s GIS Leadership Team in optimizing IS quality and compliance practices to cost-effectively meet strategic, operational, and legal/regulatory objectives. The Analyst leads activities that result in risk reduction, maturity of 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 and executes IS validation and qualification roadmap and master plans
5. Manages system validation projects
6. Executes IS risk assessments and audits
7. Ensures corrective and preventive actions are completed as planned
8. Reduces the risk-adjusted cost of quality/compliance
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 – e.g., CFR 21 Part 820/11, ISO 13485, ISO 9001, CobIT 4.1, ITILv3
3. Advanced experience conducting risk assessments and performing internal audits for medium to large enterprises
4. Superior communication and problem-solving skills; ability to identify root causes and propose effective, practical solutions that deliver measurable business value
5. Excellent process analysis skills
6. Strong project 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

Experience/Education/Certification

1. Minimum 3 years of experience in performing/leading IS risk assessments and audits
2. Minimum 3 years of progressive responsibility in IS quality within an FDA-regulated entity
3. Bachelor’s degree in technology, business, or life-sciences discipline; master’s degree desirable
4. Experience with innovative medical device or biotechnology company preferred

Equal Opportunity Employer

Illumina, Inc. - 19 months ago - save job - block
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Illumina elucidates the human genome. The firm makes tools used by life sciences and drug researchers to isolate and analyze...