Provide vision and leadership as a project manager for any approved project(s), either through the Quality Master Planning process (QMP) or at the direction of a quality system steward. Specifically, Project Manager will lead a cross-functional team of company professionals to evaluate, design, build, and implement solutions to assist in the continuous improvement of a portion of the quality system. As an experienced project manager, will manage the projects that have the most complexity and will coach project specialists in the management of their individual project work streams.
Assist Quality Assurance leadership in the prioritization of projects to obtain resources and funding. Work collaboratively across functions, regions, and business units to develop the individual project strategies and tactical plans to deliver results. Interact with a variety of internal and external stakeholders to secure input, support, and resources. Assist in the facilitation of change in business practices.
The ideal candidate is able to demonstrate success leading assigned projects to success, excellent individual project management skills, ability to manage aspect of projects through others, effective verbal, written and presentation skills.
Duties and Responsibilities
· Lead assigned quality system improvement sub-projects, determine objectives and deliverable, and ensure achievement. Collaborate with appropriate quality and compliance experts in the design and implementation of projects.
· Assist in the development and delivery of appropriate project business plan, including resources, costs return on investment, and timing.
· Ensure project deliverables meet regulatory and corporate standards.
· Collaborate with QA and other functional leaders to determine appropriate organizational structures and assist in the acquisition of internal and external talent required for assigned project deliverables
· Monitor project progress, including budgets, interim milestones, and final deliverables.
· Manage individual project challenges and recommends solutions.
· Identify and address areas of project risk, and implements strategies to mitigate project risks.
· Regularly communicate status to individual team members, project team leadership, and company leadership as required.
· Partner with a variety of function, region, and business resources to develop and execute business plan, facilitate collaboration to achieve project objectives.
· Assist in implementing permanent changes to business practices to ensure overall effectiveness of the company.
· Coach and develop individual team members to facilitate their professional growth.
· Bachelor Degree, Engineering
· Minimum 5 years’ experience in Marketing, R&D, Quality, Clinical, etc.
· Minimum 1 year project management experienc
· Minimum 2 years Project Management experience
· PMP Certification
· Knowledgeable of laws, regulations and standards for medical device industry
· Experience managing projects in the medical device/pharmaceutical/biotechnology industry
· Ability to drive and influence organizational change
· Experience presenting, interacting and influencing management decision makers
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