Program Leader Position Requirements:
- It is important that the candidate has broad experience as a program leader with integration of Quality Management System (QMS) projects in the Biopharmaceutical industry and not just IT project management.
- The candidate should have a proven track record as program manager delivering large programs which are cross site/ functional in nature. Able to work effectively and efficiently toward goals in a complex, diverse environment with multiple and changing demands.
- Should have experience integrating and aligning competing priorities across functions, strong experience communicating at senior management level to steering committees and stakeholders.
- Should have experience integrating business processes and IT systems in a regulated and validated environment.
- Experience with Software Development Life Cycle (both Agile and Waterfall) and working in Veeva is a significant plus.
This program will implement streamlined and harmonized QMS processes on a new company wide platform using a commercially available, Software as a Service (SaaS) solution.
QMS for the following processes (Commercial and R&D operations)
- Change control
- Stand-alone Actions
- Audits/Investigations/Action Management (CAPA)
- Product Quality Complaints
- Notification to Management
QMS IT Solution , including Analytics
Data Migration and Archive
Integrations with systems program which consists of multiple QMS processes. The Program Leader is the primary point of contact for the program and manages all project activities including project kickoff meetings, recurring status meetings, executive sponsor meetings, reporting, and risk tracking. The Program Leader will work to manage resources to attain project deliverables and coordinate project communication for all stakeholders. The Program Leader will serve as a pro-active problem solver and help identify, document, resolve or escalate major risks and issues.
The Program Leader will deliver the following activities for this project:
- Contributes to planning, executing, controlling, and closing the Project to ensure the Program is delivered to scope and meets time, cost and quality objectives
- Utilizes GPS standards and methodologies to verify scope, schedule, budget, monitor and control
- Ensures business objectives and project benefits are identifiable, measurable, and realized Monitors and tracks project progress, and leads project team to successful on-time and on-budget delivery of project
- Change management strategy, planning and delivery -
- Support execution of change management strategy and plan and work breakdown
- Define change metrics for the project and measure change effectiveness
- Stakeholder identification and management
- Collaborates with the Project Leader and internal stakeholders to manage expectations and mitigate risk
- Present and facilitate and capture notes and actions from the Steering Committee meetings
- Identify and analyze key stakeholders (influence/impact/support)
- Develop and implement stakeholder engagement activities
- Facilitate leadership alignment and develop leadership action plans
- Develop project communications strategy, approach and plan for all levels of organization including executive management
- Develop communications messaging and launch via pre-defined channels
- Deliver pulse checks/other surveys to measure awareness and effectiveness
Skills & Competencies
- Organization — Ability to manage multiple priorities and resources in a dynamic environment across various departments, and organize complex information.
- Communication: Due to the complexity of Program which is cross site/ functional, must have the ability to deliver communications across all levels of the organization
- Judgment and Decision Making — Considers the relative costs and benefits of potential actions to choose the most appropriate one.
- Critical Thinking — Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Must possess initiative with strong analytical and problem-solving skills.
- Attitude & Teamwork– Projects confidence tempered with humility. Must be a team player willing both to steer the team towards success and to fully support the team when others are steering.
- Problem Sensitivity —Ability to tell when something is wrong or is likely to go wrong. Recognizes there is a problem and escalates or informs the resources who can address the problem.
- Making Decisions and Solving Problems — Analyzes information and evaluates results to choose the best solution and solve problems.
- A Bachelor degree in arts or sciences or engineering is required.
- A master’s or an MBA preferred.
Program management Experience:
- At least 5 to 10 years of program management experience.