GMP Compliance Project Lead
hace 16 horas
About the Role:
">We are seeking an experienced GMP Compliance Project Lead to lead and manage projects in our aseptic areas
">The ideal candidate will have a strong background in project management, particularly in regulated pharmaceutical and medical device industries
">Responsibilities:
">- ">
- Develop project timelines, resource allocation plans, and budgets to ensure timely and on-budget delivery">
- Coordinate and oversee all stages of project execution from design through to FDA submission">
- Lead complex projects related to development, commissioning, process development, and validation of aseptic pharmaceutical or medical device products">
- Ensure compliance with FDA and other regulatory bodies' requirements">
- Prepare and review documentation for FDA submissions">
- Work closely with internal stakeholders to ensure cross-functional alignment and timely execution of project milestones">
- Manage risk assessments and mitigation strategies">
Requirements:
">Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred)
">8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry
">Proven track record of leading projects through FDA submissions
">Strong knowledge of FDA regulations, aseptic processing, validation protocols, and good manufacturing practices (GMP)
">Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing
">What We Offer:
">A competitive salary and benefits package
">The opportunity to work on complex projects with a talented team
">Professional development opportunities
-
Quality Assurance Project Lead
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completoAt Qrc Group Llc, we are seeking a highly skilled Quality Assurance Project Lead to oversee projects focused on the implementation of digital and AI solutions. This individual will drive process performance and enhance operational excellence by leading initiatives related to data integrity compliance. The successful candidate will ensure alignment with Good...
-
Project Director Aseptic Operations
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completoJob SummaryWe are seeking an experienced Project Manager to lead our aseptic operations team. The successful candidate will have a proven track record of managing complex projects from design to FDA submission.Key ResponsibilitiesThe Senior Project Manager Lead will be responsible for:Leading and managing cross-functional teams to achieve project...
-
GMP Process Expert
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completoQrc Group Llc is seeking a highly skilled GMP Process Expert to join our team. In this role, you will be responsible for ensuring compliance with GMP regulations and developing process validation strategies that meet industry standards.You will work closely with cross-functional teams to develop and implement process validation strategies, lead projects that...
-
Senior Project Manager Lead
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completoCompany OverviewThe Qrc Group, LLC is a leading provider of innovative solutions for the pharmaceutical and medical device industries.Job DescriptionJob Title: Senior Project Manager LeadReports to: Director of Aseptic OperationsLocation: Remote (with occasional on-site visits)Responsibilities:Lead and manage complex projects related to the development,...
-
Manager Aseptic Pharmaceutical Projects
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completoProject Management ExpertiseThe Qrc Group, LLC is seeking an experienced Project Manager to join our aseptic operations team. As a Senior Project Manager Lead, you will be responsible for leading and managing complex projects from design to FDA submission.Responsibilities and RequirementsResponsibilities:Lead and manage cross-functional teams to achieve...
-
GMP Compliance Specialist
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completoResponsibilities:Develop project timelines, resource allocation plans, and budgets to ensure timely and on-budget delivery.Prepare and review documentation for FDA submissions and other regulatory filings.Manage risk assessments and mitigation strategies to address project challenges.
-
Senior Aseptic Project Manager
hace 1 día
San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completoAbout the Role:">We are seeking an experienced Senior Aseptic Project Manager to lead and manage projects in our aseptic areas. The ideal candidate will have a strong background in project management, particularly in regulated pharmaceutical and medical device industries.">Responsibilities:">">Develop project timelines, resource allocation plans, and budgets...
-
Construction Project Coordinator
hace 6 días
San Juan, San Juan, Puerto Rico Peoplelift A tiempo completo**About Peoplelift**We are an innovative construction management company based in San Juan, Puerto Rico. Our team is dedicated to delivering exceptional results for our clients through our expertise and commitment to safety.About the Role:We are seeking an experienced Construction Project Manager to lead our commercial and mixed-use development projects in...
-
Digital Solutions Implementation Director
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completoDigital Solutions Implementation Director - Join us at Qrc Group Llc in shaping the future of quality assurance. As a key member of our team, you will be responsible for designing and implementing comprehensive digital solutions that drive business success. Your expertise in data integrity compliance and Good Manufacturing Practices (GMP) will ensure...
-
Puerto Rico Project Director
hace 6 días
San Juan, San Juan, Puerto Rico Peoplelift A tiempo completoAbout PeopleliftWe are a dynamic construction management company based in San Juan, Puerto Rico. Our team is committed to delivering exceptional results for our clients through our expertise and commitment to safety.Job Description:We are seeking an experienced Project Manager to lead our commercial and mixed-use development projects in the San Juan...
-
Quality Assurance Project Lead
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completoAt Qrc Group Llc, we are seeking a Quality Assurance Project Lead to join our team. This role will play a crucial part in ensuring the timely release of materials and products by managing projects related to laboratory testing, method validation, and equipment qualification.The ideal candidate will have experience in regulated industry and possess strong...
-
Regulatory Compliance Specialist
hace 16 horas
San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completoJob DescriptionThe Qrc Group, LLC is looking for a highly skilled and experienced Aseptic Operations Lead to join our team. As an expert in aseptic processing, you will be responsible for ensuring high-quality production and compliance with industry standards (e.g., GMP, FDA, EMA). Your primary focus will be on leading efforts in the design, commissioning,...
-
Senior QA Program Manager
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completoQrc Group Llc is a leader in delivering cutting-edge digital solutions that transform businesses. We are currently seeking a Senior QA Program Manager to join our team. As a key member of our team, you will be responsible for overseeing the implementation of digital solutions, driving process performance, and enhancing operational excellence. Your expertise...
-
Regulated Industry Validation Lead
hace 7 días
San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo**Job Description**Qrc Group, Llc is seeking a highly skilled MS&T Validation Specialist to lead projects focused on technology transfer and process optimization.As a key member of our team, you will oversee activities related to process validation, troubleshooting, and the introduction of new products or processes.You will serve as a liaison between R&D,...
-
Aseptic Operations Lead
hace 16 horas
San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completoAbout the RoleWe are seeking a talented and experienced Regulatory Compliance Specialist to join our team at Qrc Group, LLC. As an expert in aseptic processing, you will be responsible for ensuring high-quality production and compliance with industry standards (e.g., GMP, FDA, EMA). Your primary focus will be on leading efforts in the design, commissioning,...
-
ASEPTIC PROCESS ENGINEER LEAD
hace 5 días
San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo**About Qrc Group, Llc**At Qrc Group, Llc, we are committed to excellence in aseptic processing and manufacturing. Our team of experts is dedicated to delivering high-quality products that meet regulatory requirements.As our Sr. Aseptic Process Engineer, you will lead efforts in designing, implementing, and improving aseptic processes and systems. You will...
-
Federally Declared Disaster Project Manager
hace 4 días
San Juan, San Juan, Puerto Rico Heartland Consulting A tiempo completoJob Description\At Heartland Consulting, we are dedicated to providing exceptional service to our clients and communities. As a Disaster Recovery Lead, you will play a critical role in helping us achieve this mission.\Our ideal candidate will have a strong background in disaster recovery, with experience managing complex projects and teams. They will possess...
-
Regulated Pharmaceutical Projects Director
hace 16 horas
San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completoOverview:">Qrc Group, LLC is a leading provider of contract manufacturing services to the pharmaceutical and medical device industries">We are seeking an experienced Regulated Pharmaceutical Projects Director to lead and manage projects in our aseptic areas">Job Description:">The Regulated Pharmaceutical Projects Director will be responsible for developing...
-
Financial Project Coordinator
hace 7 días
San Juan, San Juan, Puerto Rico Xpt A tiempo completoXpt is seeking a skilled Financial Project Coordinator to join our team. This role is responsible for reviewing project budgets and providing pre-billing information to project managers.In this position, you will offer cost estimates, prepare invoices, and manage the financial elements of multiple projects. You will also ensure precise financial tracking,...
-
Financial Project Manager
hace 7 días
San Juan, San Juan, Puerto Rico Xpt A tiempo completoOverview:Xpt is a leading organization that requires a skilled Financial Project Manager to manage the financial aspects of projects.Key Responsibilities:Reviews project budgets and provides pre-billing information to project managers.Offers cost estimates and prepares invoices.Manages, analyzes, and reports on the financial elements of a project.Ensures...