Project Director, Quality & Regulatory Assurance

Company: Cardinal Health ( Learn More )

General Information
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Job Description

Cardinal Health currently has a great opportunity available for a Project Director, Quality & Regulatory Assurance.  The Project Director will develop, execute and effectively manage successful completion of key priorities such as remediation of technical files to ensure adherence with European Union MDD and MDR regulations, interact with clinical and biotoxicity departments to ensure proper clinical and toxicological evaluations for all products marketed in Europe, properly interact with R&D to ensure we have current and accurate design control files.  This Project Director will interact mainly with VPs and Directors of Marketing, R&D, Clinical, Operations, Regulatory Affairs, Quality and Sales to ensure a harmonized strategy and to coordinate activities between teams.  

Job Responsibilities

Project management:

  • Manage the process and coordination of large enterprise-wide Quality & Regulatory initiatives related to a company-wide upgrade of all technical and design files to ensure compliance with MDD and new MDR regulations
  • Successfully lead, organize, and control multiple large projects and multiple project teams / work streams as needed including coordination between RA, R&D, Quality, Operations, Clinical and Marketing teams
  • Formulate, define, and gain consensus on project scope and objectives, deliverables, and milestones with all stakeholders including the leadership team from three business units (Legacy, Cordis and Patient Recovery)
  • Ensure alignment between the project and other functional stakeholders such as Supply Chain, Clinical, Design Quality, RA Manufacturing, Finance, and Commercial R&D
  • Develop project plan to manage end-to-end activities and the execution of the project(s)
  • Establish, maintain and manage QRA project expectations and overall project performance
  • Manage workload planning and ensure work is on schedule, on budget, and meets business needs
  • Provide strong project management leadership, guidance and mentorship to the team on creation and execution of project deliverables
  • Collaborate with leadership and team members to ensure flawless execution of project activities
  • Monitor and track project performance to ensure on-time completion of projects and tasks
  • Proactively manage changes in project scope, identify potential crises, and devise contingency plans
  • Identify and track business disruption and/or project issues and risks; develop and execute mitigation plans; resolve issues and risks
  • Ensure proper execution of the risk plan throughout the projects lifecycle and proactively address/resolve any performance issues
  • Escalate issues that threaten project schedules early and develop mitigation plans
  • Schedule and coordinate weekly / bi-weekly project team meetings and assure timely delivery of weekly project status reports to all stakeholders
  • Attend project meetings to document action items, key decisions, key issues and drive next steps
  • Set project goals and metrics for project timelines and review performance against the goals
  • Measure project performance using appropriate tools and techniques, including review and validation with stakeholders and leadership team
  • Identify and manage project dependencies and critical path
  • Be responsible for project related timelines
  • Oversee the creation of work products by other team members to ensure quality
  • Coach and mentor project team members. Assist junior resources in developing realistic project goals and monitor ongoing development (as appropriate)
  • Interact with all operational divisions of Cardinal Health, across multiple levels of the organization, and successfully navigate demands across functions
  • Under general direction and minimal guidance, uses best practices and knowledge of internal or external business issues to improve project delivery
  • QRA-specific job responsibilities:

  • Knowledgeably represent QA & RA teams in meetings and forums
  • Work with department heads to ensure assurance of quality, compliance and timeliness of quality and regulatory work
  • Understand and describe the interrelationship of QA & RA activities with other functional areas of the organization
  • Assist global QA & RA team to develop strategies and actions to ensure compliance with MDD and MDR regulations
  • Participate in the development and implementation of Cardinal Health quality and regulatory policies, processes, systems, and SOPs as applicable and train key personnel on them
  • Support QA & RA team members globally by coordinating key cross-functional activities and resolving issues
  • Support the development of quality and regulatory strategies and plans supporting three business units
  • Understand the requirements for MDD and MDR compliance and coordinate execution though global teams
  • Identify issues and risks associated with MDD and MDR compliance, develop mitigation plans and resolve risks
  • Knowledgeable in managing complex quality or regulatory projects and gaining support from different stakeholders to gain consensus on path forward
  • Be a liaison between QA / RA and other functions (Operations, R&D, Clinical, etc.)  by driving collaboration and information sharing across the discipline teams
  • Develop and present QA & RA deliverables as required by the remediation team
  • Assist QA & RA teams develop resource plans and business case to support the resource requirement
  • Contribute to the continuous improvement of procedures and processes with focus on increasing efficiency, improving quality and client satisfaction, and reducing risk
  • Support research and project management for projects across all phases of the project life-cycle
  • Support Senior Vice President of QRA for routine and non-routine project related activities
  • Perform other duties assigned by supervisor
  • Deliverables

  • Project plan for MDD and MDR remediation for all business units
  • Weekly 4UP for global remediation core team (RA, Q, R&D, Clinical)
  • Create and manage Action Tracker and Risks for Quality & Regulatory
  • Coordinate relabeling strategy for all products marketed in Europe
  • Prepare slide presentations for management briefings
  • Develop and deliver project communications, including status reports
  • Provide weekly updates to senior leadership team on project status
  • Compose, edit, and deliver written and verbal communications
  • Qualifications

  • Ability to manage multiple high-intensity simultaneous projects of great importance
  • Ability to continuously evaluate and reorder priorities for self and team as business needs dictate
  • Demonstrated ability to establish and maintain effective relationships and partnerships with key stakeholders
  • Knowledge of project management software
  • Technology savvy with ability to communicate requirements
  • Ability to document key decisions discussed during project meetings
  • Ability to handle multiple tasks and have a strong attention to detail
  • Successful performance in a high-intensity work environment
  • Strong analytical and problem solving skills 
  • Excellent oral/written communication and presentation skills
  • Strong interpersonal, communication, facilitation and presentation skills
  • Prepare and deliver effective presentations for external and internal audience
  • Strong organizational skills and high attention to detail
  • Ability to deal with high stress situations is a must
  • Job Requirements

  • Master’s degree in science or engineering; MBA highly preferred
  • PMP (Project Management Professional) certification preferred
  • 10+ years’ project management experience in remediation, mergers, acquisitions and/or integration of large companies
  • 5+ years relevant Quality & Regulatory experience
  • 10+ years well rounded leadership experience in other functional areas such as Manufacturing, Supply Chain, Operations etc.
  • Experience leading Quality & Regulatory work streams in remediation, acquisition and/or integration environment
  • Demonstrated strong project management skills and tools experience, including: Project Charter, Statement of Work, Project Planning, Scope management, Change management, Time and Resource management, Risk Management, and core project management concepts such as EAC, ETC, BvA, EV, and WBS
  • Advanced skill in Microsoft Office (Excel, Word, PowerPoint) applications
  • Knowledgeable in Quality Management System development, modification, remediation, and/0r integration with new organization
  • Knowledge in preparation and delivery, both simple and increasingly complex submissions, to achieve successful regulatory approvals and maintenance of product licenses across a range of markets
  • Knowledge of QA & RA compliance
  • Knowledge of product labeling requirements in medical device industry
  • Ability to travel as necessary (up to 50%)
  • Job Requirements