Senior Director, Design Control- Cambridge Ma- Hybrid
hace 1 mes
Senior Director, Design Control- Cambridge MA- Hybrid SENIOR DIRECTOR, DESIGN CONTROL - CAMBRIDGE MA - HYBRID
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.
Responsibilities: Lead and manage the IVD design control team, providing direction, support, and mentorship. Develop and implement strategic plans for IVD design control activities in alignment with company objectives and ensure compliance with applicable regulations and standards. Collaborate with Regulatory Affairs and provide support during internal and external audits and inspections. Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, IVDR, CLIA, and other applicable standards. Establish and maintain IVD design control procedures, templates, and tools. Integrate robust ISO14971 risk management processes into design and development phases. Oversee the development of design history files (DHFs) and technical files (TFs) to ensure completeness and accuracy. Lead IVD design control activities for new product development projects. Coordinate with cross-functional teams to ensure cohesive and compliant product development. Monitor project timelines, budgets, and resource allocation. Drive periodic improvement initiatives to enhance IVD design control processes. Implement lessons learned from post-market surveillance to improve IVD design control practices. Develop and deliver training programs on IVD design control requirements. Promote a culture of quality and compliance within the organization. Expected travel needs approximately 25%. Qualifications: Minimum of 10 years of experience in design control within the medical device or clinical laboratory industry. PhD in a science-related field preferred. In-depth knowledge of FDA regulations, ISO 13485, ISO14971, IVDR, CLIA, and other relevant standards. Experience with Laboratory Developed Tests (LDTs) and understanding of their regulatory requirements. Strong project management skills with experience leading cross-functional teams. Proven leadership experience with the ability to manage and mentor a team. Strong interpersonal and communication skills. Ability to multitask and possess strong creative thinking and problem-solving skills. Benefits of Working at ICON: Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent. We offer competitive salary packages, annual bonuses, and a range of health-related benefits.
ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.
If you need a reasonable accommodation for any part of the application process, please let us know.
#J-18808-Ljbffr
-
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoSenior Director, Design Control - Cambridge MA - HybridICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.At ICON, it's our people that set us apart....
-
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoSenior Director, Quality Systems Medical Device (Hybrid) page is loaded Senior Director, Quality Systems Medical Device (Hybrid) Apply locations Boston, MA time type Full time posted on Posted 30+ Days Ago job requisition id REQ-23010 Job Description General Summary: The Senior Director, Device Quality Systems owns the strategic direction, design and...
-
Strategic Fund Finance Leader
hace 3 semanas
Puerto Diablo Barrio, Puerto Rico Cambridge Associates A tiempo completoAbout Cambridge AssociatesCambridge Associates is a leading global investment firm that helps non-profit institutions, pension plans, and private clients achieve their philanthropic goals, plan obligations, or personal objectives through tailored investment portfolios. Our comprehensive range of services includes acting as an outsourced investment office and...
-
Training Program Lead
hace 1 mes
Puerto Diablo, Puerto Rico Lorven Technologies A tiempo completoJob Title: Training Program Lead Location: Boston, MA - Hybrid Duration: Full Timea Experience required: A Bachelor's degree (Master's preferred) in Adult Education, Educational Technology, Instructional Design or Performance Improvement. At least 5 - 7 years of experience in the planning, analysis, design, development, implementation, and evaluation of...
-
UX Designer Hybrid Boston MA NH W2 Only
hace 3 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Title: UX Designer Hybrid Boston MA NH W2 OnlyJob Summary: We are seeking a skilled UX Designer to join our team in a hybrid role based in Boston, MA or Nashua, NH. The ideal candidate will have 5+ years of experience in UX or a related field and be proficient in agile team delivery.Responsibilities:Design and develop user-centered digital...
-
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoStrategic Sourcing Associate Director, Cell and Gene Therapy Raw Materials (hybrid) page is loaded Strategic Sourcing Associate Director, Cell and Gene Therapy Raw Materials (hybrid) Apply locations Boston, MA time type Full time posted on Posted 6 Days Ago job requisition id REQ-22715 Job Description General Summary: As the Associate Director of Strategic...
-
Director, Quality Engineering
hace 1 mes
Puerto Diablo, Puerto Rico Vertex Pharmaceuticals A tiempo completoJob Description General Summary: The Director ,Quality Engineering is responsible for leading quality improvement initiatives across the organization, focusing on the implementation and maintenance of structured problem-solving(Six sigma) methodologies, development, and management of KPI program, providing expertise in advanced root cause analysis, and...
-
Senior Product Design Director
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoLead Product Design and StrategyKlaviyo is seeking an experienced Senior Product Design Director to lead our product design team and drive the development of our e-commerce platform.Responsibilities:Lead a team of experienced product designers to execute on company goals.Mentor and manage a world-class team, establishing clear standards for performance and...
-
Operations Director
hace 3 semanas
Puerto Diablo Barrio, Puerto Rico Abundant Housing Ma A tiempo completoJob Description**Director of Operations and Organizational Development**Abundant Housing Ma is seeking a highly skilled Director of Operations and Organizational Development to join our team. As a key member of our leadership team, the successful candidate will be responsible for driving operational excellence, developing organizational culture, and leading...
-
Senior Quality Control Director
hace 1 mes
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob SummaryWe are seeking a highly experienced Senior Quality Control Director to lead our Quality Control team and drive the development of our Enhanced Delivery Oligonucleotide (EDO) platform. The successful candidate will have a strong background in quality control and a proven track record of leading cross-functional teams to deliver high-quality...
-
Real World Evidence Associate Director
hace 1 mes
Puerto Diablo, Puerto Rico Vertex Pharmaceuticals A tiempo completoJob Description General Summary: The Real World Evidence (RWE) Associate Director is an integral member of the RWE team, who leverages expertise in epidemiology and real world data to develop fit-for-purpose observational research, and to inform internal and external stakeholders on natural history (NH) of disease and real world outcomes within their...
-
Senior Project Manager
hace 1 mes
Puerto Diablo, Puerto Rico Turner & Townsend International A tiempo completo#xa 0;Turner & Townsend Heery are seeking an OPM Senior PM/ Project Director to manage K-12 Schools, Municipal & Higher Ed construction projects in Boston, MA! This position will be responsible for overseeing assigned projects in the New England area Project, Project Manager, Director, Construction, Manager, Business Development, Business Services, Staffing
-
Sr. Director Of Global Partnerships
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoSenior Director of Global Partnerships (MassChallenge, Inc., Boston, MA)The Senior Director of Global Partnerships oversees MassChallenge's global program delivery through innovation ecosystem building programs via strategic partnerships with governments, corporations, and universities. The programs involve regional and global startup curation, innovation...
-
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoJob Title: Associate Director, Clinical Quality ComplianceLocation: Cambridge, MAAbout the role:As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. You will maintain a state...
-
Senior Structural Engineer
hace 1 mes
Puerto Diablo, Puerto Rico Colliers Engineering & Design A tiempo completoOverview:Bergmann, an affiliate of Colliers Engineering & Design, is currently seeking a senior structural engineer to join our Water group. We have needs for structural engineers at various experience levels. Our Water Discipline is growing, and we have exciting projects to engage motivated engineers who enjoy working on a variety of projects varying from...
-
Associate Creative Director
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoAbout the RoleWe are seeking a highly motivated and resourceful Associate Creative Director to join our rapidly growing Creative Services team at Jobleads-Us. As a senior member of the creative team, you will help establish design guidelines and review the team's output to ensure high-quality design.About the RoleAs a well-rounded and highly-motivated...
-
Associate Director, Quality Control
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoAssociate Director, Quality Control Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen's pipeline. In addition, this position will be required to actively support the preparation of regulatory...
-
Supervisor, Gis Records
hace 1 mes
Puerto Diablo, Puerto Rico Eversource A tiempo completoSupervisor, GIS Records (Hybrid)09/18/2024Locations: Dorchester, MassachusettsRole and Scope of Position:Oversees the processing of Transmission, Substation and Distribution System changes into GIS, DB/UG, and other System asset registries in compliance with GIS Standards and Procedures. Directs the development and implementation of GIS Standards and...
-
Senior Director Of Development
hace 1 mes
Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completoSenior Director of Development About the Company Mission-driven organization advancing glaucoma research & providing patient education resources IndustryNon-Profit Organization Management TypeNon Profit Founded1978 Employees11-50 Specialties Glaucoma Research Project FundingPatient Education for glaucomaAnnual Glaucoma Symposium and Forumand Publicly...
-
Quality Control Senior Manager
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoQuality Control Senior ManagerJob Description General Summary: The Quality Control Senior Manager will be responsible for supporting the establishment and oversight of a new QC centralized external contract lab and management of existing contract testing labs. The position will manage GMP release and stability activities in support of clinical and commercial...