Director, Product Lifecycle Management 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're seeking a dynamic and experienced Director of Product Lifecycle Management (PLM) to lead our PLM team and drive excellence in PLM 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 PLM processes and systems, and work collaboratively to drive excellence in PLM performance

• Build and lead a high-performing PLM 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

• Identify and implement process improvements to enhance product quality, reduce costs, improve customer experience and shorten time-to-launch. 

Global Oversight and Control:

• Collaborate with R&D, Commercial Operations, marketing, Quality, and supply chain support teams to ensure seamless product launches and updates.

• Lead, develop, engage, and mentor the organization in standard product launch, product master data management, product data quality, product lifecycle training, product design/controls and document control business processes

• Oversee the entire product lifecycle, from ideation to end-of-life, ensuring efficient processes and resource allocation. 

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

• Responsible for budgeting and coordinating company-wide requirements to ensure a compliant, efficient, and effective system

• Establish the strategic enterprise data model for the company on the end-to-end flow of product information

• Set the strategic end-to-end strategy on business transformation, including evolving business processes, enterprise data governance, and the future of work within the organization

Subject Matter Expert:

• Serve as the company SME for PLM

• Lead all 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 PLM processes

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

Requirements:

• Bachelor’s degree in engineering, business or related fields, advanced degree is preferred

• Proven experience in product life cycle management Operations principles, business process, 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 E