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Req Intake Form Attached
Location: Lake Forest, IL
1. POSITION SUMMARY
The Agile PLM (Product Lifecycle Management) Project Manager will be responsible for planning, leading, and coordinating activities of the Agile PLM quality processes, document management migration and ETR (Electronic Training Records) project (hosted in Oracle) to ensure that project goals are accomplished, driving the project forward to a successful delivery to stakeholder's satisfaction, on time, quality and to budget, following Software Lifecycle best practices.
Core responsibilities will be liaising with the delivery teams, ensuring scope and progress to plan, reviewing project schedules and budgets, preparing progress reports, carrying out project planning and risk and issue management, running customer workshops and defining implementation solutions. Collating, analysing and managing information on the progress of the Agile PLM project, using Microsoft tools such as MS Project or Excel.
The project manager will ensure good project management practices are employed and that there is full and timely engagement with the Business and IT resources and adherence to corporate computer system validation procedures.
A strong background in Oracle Agile PLM, Computer Systems Validation, Medical Devices and Training Records Management is required
This job function has accountability for complying with the applicable elements of the Global Quality Framework and the Corporate Quality Management System (QMS).
2. ESSENTIAL DUTIES AND RESPONSIBILITIES - (KEY ACTIVITIES)
• Develop and implement Agile PLM functional solutions based on requirements
• Consult with stakeholders, management and business leaders and key staff members across the global Client business to collect project requirements.
• Develop and maintain project plans specifying goals, strategy, scheduling, identification of risks, contingency plans, and allocation of available resources.
• Conduct business analysis research to formulate and define technical scope and objectives of projects.
• Identify and schedule project deliverables, milestones, and required tasks.
• Act as point of contact between business personnel and IT delivery staff; PM is the key liaison between delivery personnel and project owners.
• Lead and coordinate activities of project personnel to ensure project progresses on schedule and answer questions related to project detail and deliverables.
• Adhere to the project governance framework for project reporting and documentation.
• Drive project delivery to meet the agreed scope covering time, quality and budget.
• Prepare project status reports and keep management, clients, and others informed of project status and related issues.
• Confer with project personnel to provide technical advice and resolve problems.
• Coordinate and respond to requests for changes from original specifications.
• Monitor project results against technical specifications.
• Develop and maintain technical and project documentation.
• Support Quality and Manufacturing site workshops
• Co-ordinate the multiple rounds of document migrations at Quality and Manufacturing sites
• Effective record management through documenting meetings, action items and quarterly objectives
• Works proactively and uses own initiative to ensure business needs are met effectively
• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation and effectiveness of Client Corporate Quality Management System as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behaviour with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Perform other duties and projects as assigned.
EDUCATION / EXPERIENCE
• Bachelor's degree in business or information technology from an accredited college/university or equivalent combination of education, training, and experience.
• 5-7 years' experience of IT project management and business analysis experience in implementations of Oracle Agile PLM or similar packages within the medical device or similar regulated industry. Preferably having experience of complaint management systems
• Experience of computer systems validation applied to software lifecycle development within regulatory requirements 21 CFR 820 or equivalent
• Experience of operating effectively in a project management function in a global and culturally diverse business environment.
• Strong project management and planning skills, able to manage multiple simultaneous projects in a complex environment. Effectively create and manage project teams, and develop and maintain productive project team environments.
• Ability to write concise, informative and compelling documentation.
• Strong customer service orientation, able to understand and meet the needs of a diverse client base in a positive and professional manner.
• Proactive and result-oriented, with proven ability to prioritise and organise a challenging workload, adapting to fit the changing needs of the business.
• Effective communicator with highly developed verbal and written communication skills, and the ability to explain complex, technical issues in a way that non-technical people can understand.
• Excellent interpersonal and leadership skills, with strong collaboration, facilitation and negotiation abilities.
• Systems thinking- the ability to see how parts interact with the whole (big picture thinking).
• Knowledge of and ability to ensure adherence to project/solution related compliance requirement.
• Comfortable with conflict – willingness to challenge 'conventional thinking''.
• Proficient in delivering presentations and workshops, able to engage and motivate diverse audiences.
• Able to work in a highly matrixed environment.
• Willingness to travel
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