- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Rahway based Senior Specialist, Global Development Quality Operations, is responsible for independent approval of documentation to support GMP ... components, and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or… more
- Formation Bio (New York, NY)
- …Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry ... and providing training and mentoring on global GXP/PV/CSV regulations and guidance . Ensuring preparedness for pre-approval and routine regulatory inspections… more
- Sallie Mae (Indianapolis, IN)
- …for future generations, for the future of education. **What You'll Contribute** The Senior Manager of Quality Assurance will be responsible for leading the ... To help them Start smart. Learn big. Students need guidance navigating this important time in their life. They...customer expectations. You may oversee a team of quality assurance professionals and work closely with cross-functional teams to… more
- Integra LifeSciences (Princeton, NJ)
- …The Senior Manager of the Tissue Technology (TT) Design Assurance Engineering department is responsible for developing Design Assurance Engineering ... Risk Management, Product Usability, Change and Design Controls. Provide guidance to and / or lead project teams by...AND RESPONSIBILITIES** + Functional Management of the Design Reliability Assurance Engineering Staff of the TT DRA organization +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of a high-growth, innovative team, the RA Specialist II will provide regulatory guidance , prepare and maintain documentation, and support submissions related ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …travel. Qualifications Bachelor's degree in a relevant field (Life Sciences, Quality Assurance , Regulatory Affairs, etc.); advanced degree preferred 7+ years of ... or biotechnology industry. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations...experience in documentation management, quality assurance , or regulatory compliance within the pharmaceutical… more
- Merck & Co. (Lower Gwynedd, PA)
- Job Description-The PDMB Regulated Bioanalytics Department is seeking a Compliane Senior Specialist and Technical Writer team within the Late Development (AdVAnce) ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and… more
- Merck & Co. (North Wales, PA)
- …quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.Be ... tools and templates to support delivery focusing on traceability, quality assurance , data conformance-and data fitness.Act as a key collaborator with statistical… more
- Tris Pharma (Monmouth Junction, NJ)
- …Director/Director, Procurement. Title and salary commensurate with experience. The Director/ Senior Director, Procurement is responsible for multiple facets of the ... contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and … more
- Verdantas (Dover, DE)
- …design work, regulatory engagement, and business development + Engage as Senior in Charge on land or site plan development, design, and permitting, stormwater ... of resilient communities?** Join our team as a **Lead Senior Land Development Engineer** and be at the forefront...next generation of Engineering leadership at Verdantas + Provide guidance and support to team members to ensure successful… more
