Job Details

  • Title: Program Lead
  • Code: RCI-29710/29719
  • Location: New Brunswick New Jersey (NJ) 08903
  • Posted Date: 11/12/2019
  • Duration: 12 Months
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  Job Description

Fusion Clinical-Medical Quality Management System Program Leader

Business Need:

  • Current Quality processes are inconsistent; opportunity to streamline & harmonize
  • Current Quality Management System (QMS) needs to be upgraded and integrated
  • Current QMS platform does not allow for transparency of individual QMS systems, nor consistency in activities across the enterprise

Objective:

  • The End to End (E2E) QMS program will allow for and implement streamlined and harmonized processes utilizing the new company wide platform that is a commercially available, Software as a Service (SaaS) solution.

Scope:

  • QMS for the following processes (Commercial, GPS, and R&D)
    • 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 internal relevant systems

Position Description:

  • The Program Leader will be primarily responsible for managing the overall program which consists of identifying 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.
  • 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 experience should include large scale projects across divisions and countries to ensure the QMS is part of a global enterprise solution.
  • The candidate should have a proven track record as program manager delivering complex, multi-disciplined large-scale programs which cover multiple geographical locations.
  • Able to work effectively and efficiently toward goals in a complex, diverse, ever changing environment with competing priorities and changing demands.
  • Should have experience integrating and aligning competing priorities within the project, while recognizing competing priorities outside of the project that span across multiple functions.
  • Strong and clear communicator with the ability to convey complex information in a thoughtful and concise manner to senior management, including steering committees and all levels of stakeholders.
  • Solid and proven track record with 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.
  • Experienced in managing team members, in addition to projects.
  • Comfortable with providing direction and leadership to individuals or entire teams, in order to stay on track and achieve the project deliverables.

The Program Leader will deliver the following activities for this project:

  • Leads the planning, execution, controls, and completion of the Project to ensure the QMS is delivered in accordance with the scope, timelines, costs 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
  • Manages the overall project progress against established timelines and budget
  • Develops a Change management strategy, including the planning and delivery as follows:
  • 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, identify and mitigate risk
  • Present, facilitate and capture notes and actions from the Steering Committee meetings
  • Identify and analyze key stakeholders to ensure strong support and influence of the QMS project
  • Develop and implement stakeholder engagement activities
  • Facilitate leadership alignment and develop leadership action plans

Communications Delivery

  • 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 in a dynamic and regulated environment
  • People – Capable of managing all levels of employees across various departments in a matrix environment
  • Communication – Skilled and proficient at delivering various types of communications across the organization
  • Judgment and Decision Making — Exercises good judgment by considering costs and benefits of potential actions, the downstream impact of those decisions, to decide on the most optimal solution
  • 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 who is willing to both to steer the team towards success, and 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.

Requirements:

  • Education: A Bachelor degree in arts or sciences or engineering is required.
  • A master’s or an MBA preferred.
  • Program management Experience: At least 7-15 years of program management experience.