Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
The Compliance Analyst will also support the LGA Compliance team with regulatory filings, training and L&G Group related deliverables as assigned. The Compliance Analyst is responsible for maintaining producer red flag guidelines and revising these guidelines in partnership with Licensing and Distri...
Quality Assurance Specialist IV. The Vaccine, Immunity and Cancer Directorate is seeking an energetic, collaborative and seasoned Quality Assurance professional with experiences preferably in Serology laboratory setting with strong knowledge in GCLP to lead and support laboratory quality activities....
The Senior Project Manager will be based on the construction project site and will be responsible for taking projects from conceptual stages through closeout. At Clayco, a Senior Project Manager is responsible for assisting with preconstruction, buying out contracts, and managing the project from st...
We are seeking a highly motivated, dedicated, and results driven Quality and Regulatory professional to join the team to fill a new leadership role supporting ancillary and cellular starting materials for the development and further manufacture of advanced therapy products in domestic and global mar...
Further, the CICI will manage instructional programs and initiatives focused on process, business management,and efficiency to achieve peak organizational performance, including the development, implementation, andongoing evaluation of training programs and initiatives within OSP. Demonstrated exper...
Additionally, this position oversees the fiscal unit, ensuringthe budget is accurately programmed, planned, and executed in accordance withthe direction of the Board and applicable laws. Additionally,responsible for budget planning, programming, and execution. ...
It is the project manager's responsibility to be successful in meeting or exceeding all of the financial goals of the project determined at the beginning of the project. You will ultimately be responsible for the entire project, represent the company on the project, provide overall management direct...
Are you an experienced Electrical Project Manager looking for your next career move? Look no further! Our leading electrical construction recruitment firm is seeking talented individuals like you to fill the role of Electrical Project Manager for one of our esteemed partners. Join one of our partner...
The Quality Assurance Compliance Specialist will work closely with the QA Manager and QA Supervisor to ensure company compliance with approved procedures and applicable regulatory standards. The Compliance Specialist will also work closely with clients and company suppliers to ensure quality standar...
Collaborate with Regional Marketing Program Managers, field and channel partners to analyze related competitive information, market and customer data; facilitate effective program development that meets multi-regional needs; ensuring global efficacy of programs and aligned execution. Performing fina...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR Associates in a technical discipline. Quality Assurance experience in a GMP environment (Drug Substance or Drug Product). ...
Quality Assurance Specialist IV. The Vaccine, Immunity and Cancer Directorate is seeking an energetic, collaborative and seasoned Quality Assurance professional with experiences preferably in Serology laboratory setting with strong knowledge in GCLP to lead and support laboratory quality activities....
Follow Project Management Framework and corporate processes to complete projects ensuring compliance with all results and project stage gate reviews. The Project Manager will coordinate cross functionally with R&D, Product Management, Marketing, Finance, Planning, QA/QC, Tech Transfer, Engineering, ...
The Senior Program Manager Ports and Borders will oversee coordination, management, and execution of all program activities to include Civil Works scoping, management and execution, delivery of products and/or services, demonstration of customer specification performance and quality, scope managemen...
The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and company quality objectives. Experience: </p> <ul> <li>BA/...
The Pharmacy Program Manager position is a 100% remote role requiring a HIPAA-compliant workspace. A Pharmacy Program Manager is a Clinical Pharmacist providing pharmacist support for an interdisciplinary care management team and members under assigned plan sponsors through conducting comprehensive ...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
The Project Manager works closely with senior management to make sure that the scope and direction of each project is on schedule, as well as coordinates with other departments for support. The Project Manager will need to focus on both Business and MIS resources, processes, and deliverables. Follow...
Perform quality planning, quality control activities, and quality assurance audits and reviews. Chimera Enterprises International is seeking a Quality Assurance Specialist to support the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO- CBRND) JPEO-CBRN...
The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives. Perform other duties as assigned<br /> <b...
Oslash; The IT Infrastructure project manager is responsible for ensuring IT and OT Infrastructure projects and services are delivered adequately, reliable and consistent to the site under assignment. Oslash; The role acts as the project manager and coordinator supporting the Site IT lea...
Ten (10) years of experience managing programs and contracts of similar scope, type, and complexity as a program or project manager. Program Manager with TS/SCI & PolyID:1912Department:TrainingLocation:MarylandDescription. Senior Program Manager with TS/SCI & Poly. JTG is seeking a Senior Program Ma...
We are seeking a highly motivated Virtual Reality Project Manager to lead our team in the successful. Knowledge of programming and 3D modeling. ...