Job Description:
- Essential Duties & Responsibilities
- Provides analytical support to the Project Management Office under minimal supervision.
- Proactively participates in processes and makes recommendations for system refinements within the Project Management Office.
- Support Planning Sessions as documentation lead and/or workstream lead.
- Performance Management Participates in the evaluation and feasibility process for potential projects.
- Provides clear direction on project requirements to meet expectations of external customers and business stakeholders.
- Interacts through program and/or project updates and reviews with all levels of management.
- Drives implementation of projects by establishing strategy, schedules, budgets, and financial analysis.
- Drives use of Project Management Methodology throughout projects.
- Approves team deliverables for project completion.
- Risk Management Leads team in risk management approaches and systems.
- Responsible for making decisions regarding the appropriate risk when there is substantial project or program impact.
- Administration
- Ensures appropriate linkages of this information to the project prioritization and/or portfolio process.
- Maximizes business results through continuous improvement in organization's ability to execute projects and programs from initiation to completion and production scale-up.
- Owning SharePoint site, tracking and execution of scope and financial deliverables and associated reporting.
- Finance Management Provides financial analysis and justification for new projects or programs.
- Monthly financial updates (submitted via SharePoint)
- Issue Resolution
- Eliminates or minimizes barriers to progress.
- Anticipates potential conflict situations, identifies and acts on proactive solutions.
- May perform other duties as assigned.
- Communication Weekly and monthly SharePoint updates of Initiative and Milestone
- Status Participation, including presenting updates/escalated items and fielding questions, in the standing global Master Planner meeting
- Escalation of issues, risks, and changes via established Integration Management Office (IMO) and Quality Workstream communication mechanisms
- Utilizing and enhancing standard reporting and communication tools to ensure appropriate and timely communication and reporting from multiple projects and quality/regulatory Core Team members
- Meeting participation/facilitation
- Quality Management Systems
- Execution to completion of harmonized process/quality system element roll-out.
- This will require collaboration with the Manufacturing Integration team
- Execution of outstanding process/quality system element assessments.
- This will include coordinating document owners and SMEs to ensure harmonized end state/content/IT tools; working with Manufacturing Integration team to develop change plans, and completing issuance/roll-out of processes
- Participation in and execution of elements of the Quality Integration Workstream Core Team and Communication Plan
Qualifications:
- Knowledge of cGMP manufacturing.
- Knowledge of Quality Systems
- Must have the ability to correctly complete high school-level mathematics.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Must be able to read, write, and converse in English.
- Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.
- Must have the ability to navigate electronic mail systems and intranet for communication purposes.
- Advanced word processing skills.
- Advanced spreadsheet skills.
- Advanced typing skills.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Must have ability to lead cross-functional teams.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must have passion to innovate and drive for solutions. Must display personal accountability for results and integrity.
- Must display eagerness to learn and continuously improve.
- Must have uncompromising dedication to quality.
- Must have relentless focus on rapid and disciplined action.
- Must have respect for individuals and the diverse contributions of all.
Education and/or Experience:
MBA/MS or Bachelors with equivalent plus 7 years project management experience and 10 years of demonstrated success leading multi-site, global or enterprise-wide programs in the medical products industry