- Merck & Co. (North Wales, PA)
- …the QMS processes managed under GRACS(Global Regulatory Affairs & Clinical Safety) Quality & Compliance .Establishes and maintains an engaged Community of Practice ... Serves as a Subject Matter Expert (SME) for functional group processes, systems , and regulatory knowledge.-Applies capabilities to enhance quality and builds… more
- Merck & Co. (Rahway, NJ)
- … Quality Management, Quality Oversight, Quality Risk Management, Quality Systems Compliance {+ 5 more}-Preferred Skills:Job Posting End ... infrastructure, business applications, laboratory instrument systems , manufacturing automation systems and data analysis packages.Endorse and build Quality … more
- Merck & Co. (Lower Gwynedd, PA)
- …our company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.-The successful Compliance Director candidate will lead a team that focuses on ... Job DescriptionThe PDMB Regulated Bioanalytics Department is seeking a Director to lead the Compliance team within...oversight, and improvement of labs processes, procedures, and data systems to ensure high- quality bioanalytical testing. -… more
- NVA (North Prairie, WI)
- …Associate Veterinarians, lead and coach support staff, and ensure regulatory compliance relating to the practice of veterinary medicine. Our Managing Veterinarian ... is also a key part of creating an environment of teamwork in which quality medicine and exceptional client service are delivered.To provide quality medicine, we… more
- Eisai, Inc (Nutley, NJ)
- …clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA conducting a ... week#LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance is from :236,900-310,900Under current… more
- Merck & Co. (Rahway, NJ)
- …into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence ... compliant supply of commercialized products for the benefit of patients. The Director of Packaging Distribution, Components and Systems COE is integral… more
- Merck & Co. (Boston, MA)
- …execution .-- Successful candidate will be accountable for timely availability of quality , reliable data to support insights needs for scientific and operational ... and monitoring solutions that enhance workflow efficiency and data integrity. - Ensure compliance with GxP and audit requirements for data usage and dashboarding. -… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Associate Director within Metrics, Analytics & Performance (MAP) has experience in clinical operations and is responsible for leading the ... SDLCManaging diverse projects and processes within GCTO/MAP Teams.Champion data quality , integrity, and reliability by designing and promoting best practices.Bridge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director… more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director...Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Insmed Incorporated (San Diego, CA)
- …they are accurately represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical ... Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the ... Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs,… more
- Merck & Co. (Rahway, NJ)
- …verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance .Demonstrated technical ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The associate director will be a technical subject matter expert… more
- Merck & Co. (Rahway, NJ)
- …design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance .Exceptional project ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical… more
- Insmed Incorporated (San Diego, CA)
- …and implementation of EDC systems to support clinical trials, ensuring data quality , compliance , and efficiency throughout the study lifecycle. The AD, EDC ... solutions comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance :Ensure EDC systems comply with regulatory requirements… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Processes, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems , Microscopies, Negotiation, Optical Microscopy, Product ... Commercialization, Production Process Development, Project Management, Prototyping, Quality Management Systems (QMS), Self Motivation {+ 3 more}-Preferred… more
- Merck & Co. (Rahway, NJ)
- …our external outreach to the scientific pharmacometrics community.Evaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support ... leader to drive pipeline impact and lead a talented group of pharmacometricians.This director will be part of a leadership team responsible for applying traditional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures for the signaling activities to assure ... continuous improvement around development of new signal workflow/process, development of quality systems and tools, updates to templates and procedural… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management systems .Preferred but Not Mandatory: Medical practice experience ... product profile (TPP) development, due diligence projects, and clinical-regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design and… more
