Project Leader (Contract Role)

Job Summary

Responsible for the development, tracking and execution of detailed project plans for projects, changes and / or initiatives that affect Global API Technical and Supply Management. Responsibilities will include the development of project charters, project related documents and in detailed project management, execution and implementation of Global API initiatives.     

Job Responsibilities

• Lead cross-functional, Global API (Active pharmaceutical ingredient) Projects, Changes and initiatives, serving as the project lead and primary contact for assigned projects at Apotex, throughout the development of project plans to successful project completion within the required timeline.


• As change owner work with Apotex hubs, sourcing department, internal cross-functional departments and supplier to resolve any technical, quality or regulatory related issues related to API/Excipients for NPD (New Product Development), Launch and PLCM (Product Life Cycle Development) commercial products.


• Facilitate and drive activities for SDC (Supplier Drive Change) and NSQ (New Source Qualification) projects for API/Excipients from the receipt of change to closure of Change Control Records (CCRs) through Quality Management System (Trackwise system).


• Review internal/external technical reports, interpret data/issues, make sound technical decisions, participate in API related investigations and support deficiency responses related to filing of SDC or NSQ projects.


• Demonstrate developed project management skills by utilizing tools, systems, methodologies and software to lead, plan, manage and execute all Global API related projects, changes and/or initiatives.


• Understand time-sensitive nature of managing changes by minimizing and/or eliminating delays within the critical path. Work with cross-functional areas to identify and/or manage project risk by allocating/scheduling/prioritizing tasks and decision-making responsibilities to appropriate team members (including sourcing, analytical, technical, regulatory strategy/filing, API procurement, validation and stability) to ensure project success, completion and implementation.


• Facilitate and participate in cross-functional discussions and meetings to understand the scope/risk of a change, engage stakeholders, identify solutions and prioritize projects. Define implementation plans and strategies. Ensure the team members understand the context of the change relative to the history or current situation for the project being discussed.


• Execute projects based on Global API priorities established by the Global API management team.


• Support the establishment of a communication framework to inform stakeholders of the progress, issues and proposed contingency plans. Represent GAPI as requested by Apotex internal groups regarding issues pertaining to API for problems to be efficiently addressed with the supplier. Escalate issues as appropriate.


• Identify needs and implement improvements for Global API processes and participate in the regular review and revision of existing SOPs to ensure accuracy and compliance.


• Preparation of reports and presentations for senior management review.


• Works in a safe manner collaborating as a team member to achieve all outcomes.


• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Courage, Teamwork, and Innovation.


• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.


• All other relevant duties as assigned.

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Job Requirements

• Education

• University degree or equivalent in Business and/or Science related field OR equivalent business experience.


• University degree in Pharmaceutical science /manufacturing is an asset. 

• Knowledge, Skills and Abilities
  
  
  
  • Knowledge of pharmaceutical supplier quality and drug substance manufacturing.
  
  
  • Excellent project management and leadership skills, with ability to multitask.
  
  
  • Knowledge of GMP and Pharmaceutical requirements
  
  
  • Ability to read and interpret technical documents. Ability to write detailed business correspondence.
  
  
  • Maintains an external network in field of expertise.
  
  
  • Competent professional, demonstrating integrity and solid facilitation skills.
  
  
  • Strong interpersonal skills and ability to relate well with internal/external customers and interact with Senior management
  
  
  • Ability to lead multi-discipline project teams in a fast-paced, rapidly changing environment.
  
  
  • Demonstrated knowledge of SAP systems, Trackwise, project management software and other relevant technology considered an asset.
  
  
  • PMP certification would be considered an asset.
  
  
  
  


• Experience
  
  
  
  • Minimum 5 years specific experience in  Drug master file (DMF) /Supplier Quality in pharmaceutical manufacturing space. 
  
  
  • 2-3 years leading drug manufacturing projects or coordinating concurrent projects of global pharmaceutical scope.