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.
- 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
- Project Coordinator Position Description:
- The Project Coordinator will be primarily responsible for managing the overall project which consists of identifying multiple QMS processes.
- The Project Leader is the primary point of contact for the project and manages all project activities including project kickoff meetings, recurring status meetings, executive sponsor meetings, reporting, and risk tracking.
- The Project Leader will work to manage resources to attain project deliverables and coordinate project communication for all stakeholders.
- The Project 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 project 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 project manager delivering complex, multi-disciplined large-scale projects 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.
- 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.
- A Bachelor degree in arts or sciences or engineering is required. A master's or an MBA preferred.
- Project management Experience: At least 7-15 years of project management experience.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: firstname.lastname@example.org
ALPHA'S REQUIREMENT #20-00458
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE