In this position, you will have the overall responsibility for the successful project execution plan for injectable products.
You will manage the lifecycle of a project starting at the approval of the business case, or CDMO contract signature until the scope is completed.
As the Senior Project Manager, you will work closely with multi-functional leaders and team members, as well as external partners, to ensure proper coordination of the activities in terms of timelines, quality and within budget along the project lifecycle.
Responsibilities & Duties :
- Lead cross functional (Operations, R&D, Quality, Regulatory, etc.) project teams for injectable products including internal New Product Development projects, and third party CDMO customers in accordance with approved processes;
- This role will include responsibilities related to the startup of a new product facility and the associated transfer of products from existing to new production lines.
Collaboration and coordination with the Capital Project team will be a critical component of this role
- Follow Project Management best practices for communication and maintenance of project performance
- Report and negotiate with internal and external stakeholders to solve project roadblocks and ensure project scope, schedule, budget & quality;
- Integrate multi-disciplinary timelines into organizational complex project plans and manage change through routine communication with project team members from project approval to launch;
- Liaise with steering committee team members to ensure milestone attainment and timely delivery;
- Effectively communicate and report changes and pivotal issues confronting projects that affect key milestones. Track action plans that have been put in place to address those key issues;
- Coordinate initiatives ensuring the success of the project and minimizing costs during a project
- Participate in implementation of continuous improvement measures related to the Project Management processes;
- Point of contact with co-development / in-licensing / out-licensing / contract manufacturing strategic partners for designated projects / partners;
- Manage in scope / out of scope changes and supports development defined change orders
- Provide project performance assessment to support continuous improvement on project design
- Responsible for composing Pharmascience Tax Credit Claim reports, for all active Development projects.
- All other tasks required by the function
Skills, Knowledge & Abilities :
- University Degree : science (B.Sc.) or engineering (B. Ing.) or equivalent / relevant experience
- Project Management Professional (PMP) or MBA Certification is an asset
- Minimum 7 to 10 years of professional experience including 5 years in a project management role
- Experience in Pharmaceutical industry is an asset
Able to influence across the organization, without direct authority
Very strong communication skills
Ability to anticipate problems and propose solutions
Demonstrate leadership in all aspects of project management including quality assurance and client satisfaction
Excellent analytical and problem solving skills, including the ability to deal with situations where information is difficult to obtain, complex or ambiguous
Highly organized and able to work independently
Excellent knowledge of GMP
Ability to work under stress and to set priorities
Strong sense of urgency and bias for action
Can handle multiple projects and large volumes of information
Proficient computer skills including Word, PowerPoint, Excel, Access, MS Project or Sciforma (Strong Project software tracking skills is a must); SAP-PS
Bilingualism (French and English) both verbally and written as the incumbent will have to read and write documentation and speak with suppliers and clients located outside the province of Quebec.