Project Leader - Supplier Driven Changes

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

1. Lead cross-functional, Global API 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.
2. 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.
3. 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).
4. 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.
5. 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.
6. 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.
7. 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.
8. Execute projects based on Global API priorities established by the Global API management team.
9. 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.
10. 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.
11. Preparation of reports and presentations for senior management review.
12. Coach / Mentor Project Coordinators in the development of the required competencies for their job.
13. Lead by example, demonstrating the values of Collaboration, Courage, Perseverance and Passion to positively influence the shift towards a Quality Culture.
14. Perform all duties and responsibilities in accordance with established GMP/cGMP operating procedures and safety standards.
15. Perform additional duties as required.

Job Requirements

• University degree or equivalent in Business and/or Science related field OR equivalent business experience.
• Minimum 5 years specific experience in API technical management/procurement and/or Material Requirements Planning disciplines.
• 2-3 years leading / managing or coordinating concurrent projects of global scope.
• PMP certification would be considered an asset.
• 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