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You will be updated with latest job alerts via email$ 152600 - 228800
1 Vacancy
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 Bachelors 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 andAI technologies for driving digital efficiency in traditional business processes
Required Experience:
Director
Full-Time