The Global Information Services (GIS) Sr. IT Quality & Compliance Analyst supports Illumina's GIS Compliance and Risk Management department in executing GIS compliance activities to cost-effectively meet strategic, operational, and legal/regulatory goals. The Sr. IT Quality & Compliance Analyst manages, coordinates and performs validation and verification activities. This position will create and manage processes that will increase operational maturity and regulatory compliance – all with the spirit of innovation and efficiency. This position interacts with all tiers of staff and management and must possess quality, regulatory and IT knowledge.
- Responsible for guiding the GIS Organization on requirements analysis, risk assessment, and validation/verification activities.
- Coordinates the Change Management process within the GIS organization.
- Reviews system changes to provide compliance assessments and closure summaries that are audit ready.
- Advises project teams and internal GIS customers on validation scope, risk, and validation approach.
- Assist and lead process improvement projects related to regulatory compliance within the GIS Organization.
- Operate independently to manage end to end compliance activities within projects.
- Develops and maintains software and hardware testing protocols (knowledge of different types of testing such as integration, unit, regression testing).
- Responsible for all IT validation documentation.
- Participates in project and system requirements gathering/authoring; coordinates activities with business users and analysts.
- Investigates root-cause of defects, failures and authors and/or investigates Non-conformance and CAPAs.
- Minimum 5 years' experience in a validation related role.
- Experience in Medical Devices, Pharmaceutical and/or Biotech Industries desired.
- Strong oral and written skills to persuade, direct and advise stakeholders on regulatory compliance processes.
- Strong organizational skills to maintain and manage multiple validation projects
- Experience with enterprise applications such as SAP, SFDC, LMS and EtQ.
- Experience with Test Management Tools such as ValGenesis, HPQC etc.
- Ability to articulate risk based validation strategy and provide tailored validation approach to meet the business needs.
- Experience and leadership in fast-paced project implementations.
- Excellent customer service and communication skills.
- Experience with regulations and frameworks – e.g., 21 CFR Part 820/11, ISO 13485, SOX, HIPAA and GAMP.
- Experience with software development life cycle activities, methodologies, testing and validation.
- Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS.
- Bachelor's degree in technology, science or business.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.