The Role
Manage complex pharmaceutical and manufacturing projects from planning through completion, including budgets, schedules, resources, risks, governance, regulatory compliance, and cross-functional coordination. Lead initiatives involving new product introduction, technology transfer, process development, lifecycle management, commercialization, change control, and process validation. Prepare reports and presentations, resolve project issues, support senior management, and ensure project goals, quality standards, and timelines are achieved.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Responsibilities:
- Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
- Establish and achieves project standards for work quality and quantity.
- Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
- Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
- Manage and track project budget(s) and timelines.
- Negotiate and reconcile the use of resources for the projects.
- Identify and anticipate schedule slips or changes and analyses the costs and resource impact.
- Actively participate in directing the evolution and defining the role of the project.
- Ensure the project goals and objects are well understood by the various functional areas.
- Maintain the master project plan and schedule for assigned projects.
- Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
- Provide senior management and department heads with project management support on an as needed basis as well as for special projects.
- Identify or leads focus area projects within the overall function of project management or related projects.
- Generate periodic updates and prepare formal presentations for required forums.
- Generate individual and more complex reports utilizing various resources.
- Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
- Anticipate resource needs and communicate to management sponsors. ** Other functions that may be assigned.
- Bachelor's degree in related area
- 6 years of Project Management experience OR
- Previous experience in change control management, project controls and capital projects.
- Demonstrated experience leading New Product Introduction (NPI), technology transfer, process development, lifecycle management, or commercialization programs. Proven ability to lead complex, cross-functional projects from business case development through execution and product launch.
- Experience developing and managing integrated project schedules, resource plans, risk registers, budgets, and governance processes.
- Process validation background will support the previous required qualifications
- Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
- Skills in working under time pressure.
- Practical project management software and spreadsheet skills, proficient computer operation skills.
- Effective verbal and written communication skills (writing and presentations).
- Bilingual (English and Spanish)
- Administrative Shift
Skills Required
- Bachelor's degree in a related area
- Six years of project management experience
- Experience with change control management, project controls, and capital projects
- Experience leading new product introduction, technology transfer, process development, lifecycle management, or commercialization programs
- Experience leading complex, cross-functional projects from business case development through execution and product launch
- Experience developing and managing integrated project schedules, resource plans, risk registers, budgets, and governance processes
- Process validation background
- Ability to manage multiple responsibilities, priorities, tasks, and projects simultaneously
- Ability to work under time pressure
- Practical project management software and spreadsheet skills
- Effective verbal and written communication skills, including writing and presentations
- Bilingual English and Spanish proficiency
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The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
