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. • Responsible to maintain and manage the status of validated applications. • Responsible for audit readiness checks. • 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. • Provide direction, support, and motivation to their team members to achieve organizational goals • Track key performance indicators, analyze data, and report on team progress to senior management • Manage Projects and operations, ensuring that resources are used effectively • Address and resolve conflicts within the team and with cross functional teams, fostering a positive and productive work environment 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: • 8 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. • Working with cross - functional team and aligning on validation strategy. • Experience validating enterprise applications and working experience with test management tools. • Ability to articulate risk-based validation strategy and provide validation approach to meet the business needs. • Experience with regulations– e.g., 21 CFR Part 820/11. • Experience with software development lifecycle activities, methodologies, testing and validation. • Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS. People Leadership: • Communicate clearly and effectively, keeping the team informed and engaged • Identify and address problems, implementing solutions to improve efficiency and productivity · Define objectives for the team, develop strategies, and implement plans to achieve those goals · Effectively delegate tasks and responsibilities to team members, ensuring that everyone is contributing to the overall goals · Enforce company policies and procedures, ensuring that employees comply with regulations Experience/Education: • Typically requires a minimum of 8 years of Life science industry experience with a bachelor’s degree; or 5 years and a master’s degree • Minimum of 3 years in people management experience All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seek ... (truncated, view full listing at source)