The Role
Manages complex pharmaceutical, biotech, and manufacturing projects from planning through execution, commercialization, and operational readiness. Oversees project budgets, timelines, resources, governance, risks, change control, regulatory compliance, and cross-functional collaboration. Leads NPI programs, develops project strategies, tracks schedules, prepares reports and presentations, supports senior management, and drives process improvements. Requires strong communication in English and Spanish and experience with SAP Ariba, SAP, TrackWise, and project management tools.
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)
- Change Control and NPI experience is required for this position
- Leads strategic and highly complex New Product Introduction (NPI) programs, from project strategy and planning through execution, commercialization, and operational readiness.
- Develops comprehensive project strategies and governance frameworks while driving execution across multiple functions and ensuring alignment among cross-functional teams and stakeholders.
- Provides strategic leadership, mentorship, and direction to project teams, fostering accountability, collaboration, and successful program execution.
- Effectively manages multiple responsibilities, priorities, tasks, and complex projects simultaneously while meeting demanding timelines and maintaining accuracy.
- Experienced in working under significant time pressure and managing complex business risks, dependencies, priorities, and competing objectives.
- Drives organizational alignment and cross-functional collaboration to ensure successful program execution and achievement of business objectives.
- Experienced in commercialization planning and ensuring operational readiness for successful product launches and transitions.
- Strong project management, organizational, analytical, and problem-solving skills, with exceptional attention to detail and accuracy.
- Proficient in project management software, spreadsheets, and computer applications, with advanced proficiency in Microsoft Office, including Excel, Word, and PowerPoint.
- Experienced in working effectively within cross-functional and matrixed organizational environments.
- Demonstrated ability to act as a strategic thinker, self-starter, persistent problem solver, tactful communicator, and effective team player.
- Excellent verbal and written communication and presentation skills, with fluency in business English and Spanish.
- Demonstrated ability to build strong relationships, influence stakeholders, and communicate effectively across all levels of an organization.
- Demonstrated capacity for professional growth and increased responsibility, with the ability to provide strategic direction and leadership in complex business environments.
- Experienced with SAP Ariba Sourcing and Contracting Modules, with additional experience in SAP, TrackWise, and project management tools.
- Experienced in Change Control, including evaluation, coordination, documentation, implementation, and tracking of changes throughout the project lifecycle.
Skills Required
- Bachelor’s degree in Science or Engineering
- Chemistry or Biology degree background
- Chemical, Industrial, or Biotechnology Engineering background
- Change Control experience, including evaluation, coordination, documentation, implementation, and tracking
- New Product Introduction (NPI) experience
- Experience leading complex NPI programs through strategy, planning, execution, commercialization, and operational readiness
- Experience developing project strategies and governance frameworks across cross-functional teams
- Experience with commercialization planning and product launch operational readiness
- Experience managing complex projects, priorities, risks, dependencies, and timelines under significant time pressure
- Strong project management, organizational, analytical, problem-solving, communication, and presentation skills
- Advanced proficiency with Microsoft Office, including Excel, Word, and PowerPoint
- Experience working in cross-functional and matrixed organizations
- Fluency in business English and Spanish
- Experience with SAP Ariba Sourcing and Contracting Modules
- Additional experience with SAP, TrackWise, and project management tools
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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
