Staff IT Security, Risk & Compliance Analyst (FDA Quality & Compliance)

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Responsibilities:

• Advises project teams and internal GIS customers on validation scope, risk, and validation approach.
• 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 Validation Documentation.
• Participates in project and system requirements gathering/authoring, coordinates activities with business users and analysts.
• Coordinates the Change Management process within the GIS organization.
• Reviews system changes to provide compliance assessments and closure summaries that are audit ready.
• Investigates root-cause of defects, failures, and authors and/or investigates Non-conformances and CAPAs. 

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

• 7+ years of experience working in 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, etc.
• 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 the 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 managing workload using IT Service Management ticketing tools, ServiceNow preferred.
• Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS.

People Leadership:

• Ensure Policies and Procedures are followed by direct reports
• Work with onshore leads for new and/or altering work assignments

Experience/Education:

• Typically requires a minimum of 7 years of related experience with a bachelor’s degree; or 5 years and a Master’s degree

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

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.