- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there’s only one choice. Senior Director , Digital Governance & LMR Lead The Senior Director , Digital Governance & ... enabling cross-functional teams to be accountable for the delivery of high quality , ethical standards of service. The role combines digital expertise with the… more
- Tris Pharma (Monmouth Junction, NJ)
- …inventory control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in ... negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory … more
- Formation Bio (New York, NY)
- …for both development and manufacturing, ensuring high- quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and review ... technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- Merck & Co. (Rahway, NJ)
- …and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to ... Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director… more
- Merck & Co. (Rahway, NJ)
- …and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ...party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate… more
- Cipla (Central Islip, NY)
- …relationships, negotiating favorable contracts, identifying cost-saving opportunities, and maintaining compliance with regulatory and company policies. Success ... Job Title: Director - Procurement, Cipla North America Reports to:...resolve any issues or disputes that may arise. Ensure compliance with regulatory requirements, industry standards, and… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Eisai, Inc (New York, NY)
- …specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner ... to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... minimum of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated… more
- Merck & Co. (Rahway, NJ)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements.-This position will lead ... DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) Team… more
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