- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality ...as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Senior Director of Quality Operations as part of the Quality team based ... in Raritan, NJ.Role OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities within the...Therapy Quality organization and a champion for quality principles and compliance . The role develops… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. Job Description About the role: The Associate Director , Clinical & Quality Process Compliance is responsible for ensuring ... meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high- quality… more
- Insmed Incorporated (NJ)
- …requires a blend of technical expertise and business acumen to ensure regulatory compliance , system integrity, and alignment with business objectives across ... alignment with business objectivesCollaborate closely with cross-functional teams including Quality Assurance, IT, CSV, and Compliance departmentsEnsure that… more
- Eisai, Inc (Philadelphia, PA)
- …and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. ... vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, ... Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent… more
- Repligen (Waltham, MA)
- …an experienced and driven IT Business Partner to represent our Manufacturing, Quality , Supply Chain, Product Development, and R&D organizations. As a Director ... implement, and optimize technology solutions that enhance operational performance and compliance . The ideal candidate brings deep knowledge of the bioprocessing… more
- Novo Nordisk Inc. (Boulder, CO)
- … programs to ensure product safety and quality Responsible for ensuring compliance with all regulatory requirements and maintaining the highest standards of ... (QA) function and serves as the leading expert in quality , compliance , and quality management...to the respective site's goals Meet or exceed business, regulatory & internal customer requirements in accordance with Novo… more
- ThermoFisher Scientific (Allentown, PA)
- …current regulatory expectations. Key Responsibilities: Support the established Quality Compliance strategy. Work to ensure continuous improvements regarding ... products and make Quality a competitive advantage by achieving outstanding GMP regulatory compliance with zero patient impacting events and drive quality … more
- Catalent Pharma Solutions (Kansas City, MO)
- …support and work with customers to resolve quality concerns as appropriate. The Quality Director is the business partner to Operations and advisor to the ... Director , Quality , BioAnalytical Catalent, Inc. is...engaged and motivated; Analyze, resolve, or assist in solving compliance and customer issues; Ensure regulatory and… more
- Insmed Incorporated (NJ)
- …company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management ... of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product… more
- Catalent Pharma Solutions (Kansas City, MO)
- …Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations. Monitor site compliance to FDA, EU and all other ... Director , Quality Position Summary Catalent, Inc....as appropriate. They will be responsible for operational and compliance performance across regulatory authorities and markets… more
- Datavant (Raleigh, NC)
- …quality -related escalations. What You Need to Succeed 8+ years of experience in quality , compliance , or regulatory roles within life sciences, digital ... to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on Director of Quality to lead product and supplier quality assurance… more
- Globus Medical, Inc. (Audubon, PA)
- … Quality , and Sterile Manufacturing Quality . This position ensures compliance with applicable regulatory requirements (FDA QSR, ISO 13485, EU MDR, ... so patients can resume their lives as quickly as possible. Position Summary: The Director of Quality provides strategic leadership and oversight of the company's… more
- Community Health Systems (Tucson, AZ)
- …leads and advances the hospital's quality improvement, patient safety, and regulatory compliance programs. This role champions a culture of continuous ... preferred Experience : 5-7 years of experience in healthcare quality , patient safety, or regulatory compliance...part of the application or hiring process, contact the director of Human Resources at the facility to which… more
- Insmed Incorporated (NJ)
- …efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials. ... the future of science, we're in. Are you?About the Role:The Associate Director , Medical Review Committee (MRC) Operations is responsible for managing the operational… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... relationships with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Lilly (Concord, NC)
- …determined to make life better for people around the world. Responsibilities The Senior Director , Global Process Owner for Quality Risk Management, as a leader ... with Lilly manufacturing facilities, external supplier organization, marketing affiliate quality operations, regulatory , research and development and other… more
- Merck & Co. (Rahway, NJ)
- …(PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Submissions {+ 5 ... microscopy and chromatography.Collaborate with cross-functional teams, including research, development, quality control, and regulatory affairs, to ensure… more
- Banner Health (Scottsdale, AZ)
- …Indian tribal lands, and the suburban cities of Chandler and Gilbert. As the Director of Quality Improvement, you will handle rounding, team facilitation, data ... from patient safety, harm reduction, clinical performance opportunities, peer review and compliance with regulatory and accrediting agencies. Serves as a… more
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