The Role
Manage pharmaceutical and manufacturing New Product Introduction projects from planning through completion. Responsibilities include maintaining project plans and schedules, tracking budgets, coordinating resources, mitigating risks, addressing regulatory requirements, managing change control, aligning stakeholders, preparing reports and presentations, and supporting continuous process improvements across cross-functional teams.
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:
Qualifications:
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.
Qualifications:
- Bachelor’s degree in Sciences (Chemistry or Biology preferred) or Engineering (preferred: Chemical/ Industrial/ BioTech)
- Proven experience leading cross-functional teams responsible for the planning, execution, and delivery of New Product Introduction (NPI) projects.
- Strong project management skills, including schedule development and management, milestone tracking, resource coordination, risk mitigation, and project execution.
- Ability to ensure project objectives are achieved within established scope, quality, cost, and timeline requirements.
- Demonstrated ability to manage multiple projects, priorities, responsibilities, and deliverables simultaneously in a fast-paced environment.
- Strong ability to work effectively under time pressure while maintaining quality, accuracy, and attention to detail.
- Experience working within cross-functional and matrixed organizational environments, with the ability to build effective relationships across multiple functions.
- Strong stakeholder engagement and communication skills, with the ability to influence, persuade, and drive alignment among diverse stakeholders.
- Excellent organizational, analytical, problem-solving, and decision-making skills, with a strong attention to detail.
- Self-starter and strategic thinker with demonstrated persistence, tact, adaptability, and ability to work effectively both independently and as part of a team.
- Excellent verbal and written communication skills, including business documentation, project reporting, presentations, and stakeholder communications.
- Fluent in business English and Spanish, both written and oral.
- Demonstrated ability and willingness to grow professionally and assume increased levels of responsibility.
- Experience with Change Control processes and the ability to manage project changes, impacts, documentation, approvals, and implementation.
- Experience with SAP Ariba Sourcing and Contracting Modules.
- Experience with SAP, TrackWise, and project management tools preferred.
- Highly proficient in Microsoft Office, particularly Excel, Word, and PowerPoint.
- Proficient in project management software, spreadsheet applications, and general computer systems.
Skills Required
- Bachelor’s degree in Sciences, preferably Chemistry or Biology, or Engineering, preferably Chemical, Industrial, or Biotechnology Engineering
- Proven experience leading cross-functional teams in planning, executing, and delivering New Product Introduction projects
- Strong project management skills, including schedule development, milestone tracking, resource coordination, risk mitigation, and project execution
- Ability to deliver project objectives within scope, quality, cost, and timeline requirements
- Ability to manage multiple projects, priorities, responsibilities, and deliverables in a fast-paced environment
- Experience working in cross-functional and matrixed organizational environments
- Strong stakeholder engagement, communication, influencing, and relationship-building skills
- Excellent organizational, analytical, problem-solving, decision-making, and attention-to-detail skills
- Excellent verbal and written communication skills for documentation, reporting, presentations, and stakeholder communications
- Fluency in business English and Spanish, written and oral
- Experience with Change Control processes, including impact assessment, documentation, approvals, and implementation
- Experience with SAP Ariba Sourcing and Contracting Modules
- Experience with SAP, TrackWise, and project management tools
- High proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint
- Proficiency in project management software, spreadsheet applications, and general computer systems
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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
