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 ERP, Salesforce etc.)
Exposure to lean, six-sigma, continues improvement, project management, data analytics and global cultures
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