- 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. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Executive Director , Chemistry, Manufacturing & Controls ( CMC) , Pre-approval Pharm will ... CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality submissions for products that may include respiratory/ inhalation, peptide,… 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. (Millsboro, DE)
- …leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance -focused with practical experience supporting regulatory ... Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. Your leadership will… 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
- Eisai, Inc (Nutley, NJ)
- …clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA conducting a ... #LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance - Remote-Based is from :236,900-310,900Under… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA and ICH regulations and guidelines Expertise in safety databases, call center telephony systems and quality systems Knowledge of NNI supported disease ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… 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 (Pittsburgh, PA)
- …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)
- …supporting compliance investigations and change management. Experience working with Quality systems . Experience working in an environment with an Automation ... to lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems , Regulatory Compliance , Results-Oriented, Technology TransferPreferred Skills: ... enhance data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity.Global Impact:Collaborate with colleagues across the US… 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
- 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. (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. (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
- Legend Biotech USA, Inc. (Raritan, NJ)
- … risks.Technology & Automation: Familiarity with modern manufacturing systems (MES, ERP, etc.) and digital transformation initiatives.#Li-BZ1#Li-OnsiteThe ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… 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
