Reporting to the Director of Engineering, the Strategic / MOB Project Manager will use the (Tampa Project/Product Development Process), systems & tools, to plan and manage/coordinate resources and activities related to projects (strategic, continuous improvement, business interruption, compliance) throughout all support groups.
Provide Project Management Leadership to the Tampa Pharma Business Operations
• Develops business case recommendations and engages site management to determine endorsement of new project opportunities.
• Champions and leads projects for process/ophthalmic drug development, continuous / cost improvement, capital, and product
• Management of projects in compliance with PMO/cGMP process and procedures.
• Management of project team members from the various other functional areas assigned to a specific program (includes team meetings, communications to teams and meeting minutes etc.).
• Responsible for developing and overseeing the capital plan.
• Responsible for engineering services compliance metrics (NC OTP,
CAPA OTP, SOP 3 Year Reviews, etc)
• Member of the Material Review Board (MRB) supporting /
approving non-conformance investigations from an engineering
• Works with Regulatory Affairs to manage process change submissions to regulatory agencies.
• Along with project team, lead the development and implementation of a project plan, schedule, budget and identifies capital requirements when applicable.
• Review and monitor program/project activities against scope, schedule and budget.
• Prepare amended budget/capital forecasts as required.
• Deliver projects to agreed timelines and budgets.
• Communicate effectively with Tampa management /RD&E management and staff regarding the status of all activities.
• Inform management in a timely manner of any problems which may result in a delay in project schedules so that appropriate action may be taken. Develops and recommends recovery plans when necessary.
• Publish monthly/quarterly project report summaries and scorecard metrics as required.
• Reviews/approves documentation that are needed for the execution
and implementation of projects.
• Expert in Project Management skill. PMI Certification a plus.
• Organized, good communicator, assertive, proven leader.
• Bachelor’s degree in science required with 8+ years of related experience.
• 5 - 7 years pharmaceutical drug development project/program management experience with specific experience in managing complex, highly technical R&D/Drug Development related activities. Regional experience a plus.
• Prior training in project management.
• Proven, hands-on, results-oriented manager with demonstrated leadership skills across functional lines and a participatory style of working effectively in a dynamic, team-oriented environment.
• Ability to communicate and interact at all levels from senior management to staff level.
• Ability to translate customer requirements into measurable design goals/input.
• Competency in Microsoft Project, Word, PowerPoint & Excel.
• Excellent verbal, written and electronic communication skills.
• Therapeutic area experience in ophthalmology or generic drug development.
• Statistical evaluation skills for process assessment a plus.
Ability to travel, ~10% overnight travel, domestic and international.
Valeant is an EEO/AA employer M/F/D/V.