Description
Job Purpose
This individual has full responsibility for facilitating and managing the cross-functional execution of assigned projects. Projects managed will be non-clinical in nature, including operations initiatives such as: technical transfers, equipment & process upgrades, contract manufacturing, operational excellence, and select business processes. This includes coordination of a global team of internal and external stakeholders.
Principal Responsibilities of the role
- Responsible for establishing and managing the project scope, critical path, and budget
- Collaborates and communicates effectively with project teams and utilizes key project management tools (Project Charter, Risk Management Plan, Project Plan, Schedule, RACI's, etc.) to effectively mitigate risks and provide clear direction
- Develops the project schedule with the team and establishes stakeholder buy-in to key milestones
- Develops and maintains resource tracking, particularly targeting constraints of common resources across initiatives or work streams
- Effectively facilitates and manages team meetings and assures that proper communication regarding the project is appropriately elevated and distributed (including presenting at key project stage and other reviews)
- Recognition and communication of compliance and business risks across projects, programs, or portfolios
- Reporting of project status to ARD Operations Leadership Team, following established escalation mechanisms when necessary
Department specific/Non-essential responsibilities:
- Leads or supports programs to improve project management processes and tools
- Responsible for insuring the complete documentation of the project
- Other duties as assigned with or without accommodation
Requirements/Expectations
Experience/Skills:
Life Sciences/Medical Devices experience
- BS degree in a technical discipline
- 5 years' experience in a manufacturing environment, ideally pharmaceutical, with 3 years' experience managing cross-functional teams
- Demonstrated experience in project management (certification a plus)
- Knowledge of cGMPs and other compliance requirements governing pharmaceutical manufacturing
- Ability to understand high level activities and needs across Regulatory, R&D, Operations, Quality, and Commercial organizations
- Ability to manage multiple projects simultaneously with little supervision
- Ability to effectively handle conflict through proactive action and direct and timely communication
- Strong organizational and planning skills
- Demonstrated ability to work within a global team
- Six Sigma Green Belt certification a plus
Competencies:
- Excellent oral and written communication skills along with ability to listen effectively to others
- Skilled in problem identification and solving, including ability to negotiate and influence
- Demonstrated competence in giving presentations to senior management
Relationship with Others:
Position reports to the Director, ARD Program Management