Assoc. Director, PLM Operations

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.

We are seeking a dynamic and experienced Associate. Director of Product & Document Lifecycle Management to lead our document management team and drive excellence in processes, systems, and performance. This role will be pivotal in developing and executing a compelling roadmap of process/system improvements, ensuring compliance with regulatory requirements, and fostering a culture of innovation and excellence.

Responsibilities:

Strategy and Leadership:

• Assess the current state of document management processes and systems, and work collaboratively to drive excellence in performance

• Build and lead a high-performing global team, and influence across the matrix to ensure high-level goals and objectives are met

• Develop and execute a compelling roadmap of process/system improvements and chart a path to execute against that roadmap and vision

• Balance longer-term strategic thinking with tactical execution of shorter-term deliverables

• Develop and coach key talent, leading by example and displaying leadership values

Best Practices:

• Embrace and thrive in a fast-paced, complex, and often ambiguous environment where innovation is at the heart of all that we do

• Establish a strong foundation of standards, protocols, and best practices

• Define communication and development plans to adopt best practices

• Provide technical guidance on approaches for novel technology, effectiveness, visualization of performance metrics, and analytical/functional testing

• Stay current with industry trends and technologies to keep the company at the forefront of managing a product enterprise

Global Oversight and Control:

• Collaborate with R&D, Commercial Operations, Quality, and supply chain support teams to ensure seamless document control processes and updates

• Lead, develop, engage, and mentor the organization in data management and document control business processes and training

• Ensure compliance with regulatory requirements such as 21 CFR 820, ISO 13485, MDSAP, IVDR, and other related standards, support and develop proactive audit controls and compliance

Subject Matter Expert:

• Serve as the company SME for Document Management and PLM System – coordinated quarterly release plans with all stakeholders and coordinated with IT on system improvements

• Lead aspects of Organizational Change Management for enterprise-wide changes to systems and processes

• Consult with technical experts and relevant stakeholders to incorporate a comprehensive, risk-based approach to processes

• Actively engage and collaborate with GIS, Commercial, and HR to integrate QMS LMS Training seamlessly into company processes

Requirements:

• Typically requires a Bachelor’s degree and a minimum of 15 years of related experience, with 7+ years of Management experience.

• Proven experience in product/document life cycle management, Operations, business processes, tools, regulatory compliance, and life science product development process.

• Expertise in leading Organizational Change Management during rapid growth and transition

• Proficiency in software tools leveraged in product life cycle management (Teamcenter/Oracle Agile, SAP/Oracle ERP, QMS, etc.)

• Exposure to lean, six-sigma, continuous improvement, project management, data analytics, and global cultures

• Exposure to Automation, RPA, and AI technologies for driving digital efficiency in traditional business processes

The estimated base salary range for the Assoc. Director, PLM Operations role based in the United States of America is: $152,600 - $228,800. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensatio