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 seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.