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Quality & Regulatory Affairs Project Manager, LATAM

Job Description

Cardinal Health currently has a great opportunity available for a Project Manager, Quality & Regulatory Affairs (QRA).  The Project Manager will develop, execute and effectively manage successful completion of key QRA priorities such as product registration transfers, exiting TSA expediently, and other projects associated with integration efforts. This is an individual contributor role requiring cross-functional leadership skills.

 

Flexible location provided the minimum language requirements are met, i.e., English and Spanish.

 

Accountabilities

 

Project management:

  • Manage the process and coordination of large enterprise wide Quality & Regulatory initiatives related to global product registration transfer from MDT Patient Recovery to Cardinal Health Inc, exiting TSA agreement expediently, transferring manufacturing capabilities to a new facility, and other initiatives as determined by the leadership team
  • Successfully lead, organize, and control multiple large projects and multiple project teams / work streams as needed
  • Formulate, define, and gain consensus on project scope and objectives, deliverables and milestones with all stakeholders including the leadership team  
  • Ensure alignment between the project and other functional stakeholders such as Supply Chain, Manufacturing, Finance, Commercial and Materials Management 
  • 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, identifies potential crises and devises contingency plans
  • Identify and track business disruption and/or project issues and risks; develop and execute mitigation plans; resolve issues and risks
  • Ensures proactive and proper execution of the risk plan throughout the projects lifecycle. Address/resolve any performance issues
  • Proactively escalates issues that threaten project schedules and develops 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
  • 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

 

Quality and Regulatory Affairs accountabilities:

  • Knowledgeably represent Quality Assurance & Regulatory Affairs (QA & RA) teams in meetings and forums
  • Work with department heads to ensure assurance of quality, compliance and timeliness of quality and regulatory work
  • Ability to understand and describe the interrelationship of QA & RA activities with other functional areas of the organization
  • Assist in developing, approving, implementing, maintaining, and ensuring Quality Agreements, with regard to terms & conditions, and that Cardinal Health interests are protected
  • Thorough understanding of TSA, TMA, rTMA agreements
  • Assist global QA & RA team develop strategies and actions to promote early and quicker exit from TSA
  • Participate in the development & implementation of CAH quality and regulatory policies, processes, systems and SOPs, as applicable, and train key personnel on them
  • Support QA & RA team members in EMEA by coordinating key cross functional activities and resolving issues
  • Support the development of quality and regulatory strategies and plans supporting Patient Recovery integration on a global scale
  • Understand the requirements for product registration transfers, formulate plan and coordinate execution though global teams.
  • Identify issues and risks associated with product registration transfers, develop mitigation plans and resolve risks
  • 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 Director - QRA EMEA during routine and non-routine project related activities
  • Perform other duties in line with business needs and as determined by management

 

Deliverables:

  • Project plan for manufacturing transfer, license transfer and TSA exit strategy
  • Weekly follow up of global QA & RA activities, manufacturing transfer
  • Create and manage Action Tracker and Risks for Quality & Regulatory
  • Prepare slide presentations for management briefings
  • Develops and delivers project communications, including status reports
  • Provide weekly updates to senior leadership team on project status
  • Compose, edit, and deliver written and verbal communications

 

 

Specialist Experience

  • Bachelors degree in science or engineering
  • Knowledge of Quality Assurance and Regulatory Affairs principles
  • 10+ years’ project management experience in mergers, acquisitions and integration of large companies
  • Progressive well rounded leadership experience in other functional areas such as Manufacturing, Supply Chain and/or Operations
  • Advance proficiency in Spanish and English (read, write, speak)
  • Knowledge of ISO 13485 standards
  • Knowledge of  Quality Management System principles
  • Skilled in Microsoft Office (Excel, Word, PowerPoint) applications
  • Ability to travel 30% of the time or as needed
  • Ability to manage multiple high-intensity simultaneous projects of great importance
  • Ability to continuously evaluate and re-order 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 and obtain results from IT
  • 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

 

What will make you stand out from the rest

  • MBA
  • PMP (Project Management Professional) certification
  • Proficiency in Portuguese

 

 

Please note that all information in this job description is accurate at the time of posting. Please be aware that companies may change details and/or closing dates without notice.

 

 

Job Summary

Company
Cardinal Health
City
Bogota
Country
  • Colombia
Industries
  • Health/Medical
Job Type
  • Full-time
Salary
  • Negotiable
Reference
GWP273097
Posted
25 March 2019
Applications Deadline
11 May 2019

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