Senior IT Security Risk Specialist
1 month ago
About the Role:
Illumina is expanding access to genomic technology to realize health equity for billions of people around the world. As a Senior IT Security Risk Specialist, you will be part of a team that enables life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Responsibilities:
- Advise project teams and internal GIS customers on validation scope, risk, and validation approach.
- Operate independently to manage end-to-end compliance activities within projects.
- Develop and maintain software and hardware testing protocols.
- Responsible for validation documentation.
- Participate in project and system requirements gathering/authoring, coordinate activities with business users and analysts.
- Coordinate the Change Management process within the GIS organization.
- Review system changes to provide compliance assessments and closure summaries that are audit-ready.
- Investigate root-cause of defects, failures, and author and/or investigate Non-conformances and CAPAs.
Requirements:
- 5+ years of experience working in the Life Sciences industry focusing on Computer Systems Validation.
- 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, LMS, Salesforce, and EtQ.
- Experience with Test Management Tools such as HP Quality Center, ValGenesis, and TFS.
- Ability to articulate risk-based validation strategy and provide validation approach to meet business needs.
- Excellent customer service and communication skills.
- Experience with regulations and frameworks – e.g., 21 CFR Part 820/11, ISO 13485, and GAMP.
- Experience with software development lifecycle activities, methodologies, testing, and validation.
- Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS.
Experience/Education:
- Typically requires a minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree.
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.
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