- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems processes within… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Cipla (Fall River, MA)
- …associates to ensure they are qualified prior to beginning their daily functions. Acts as quality lead for all shop floor questions/concerns. Acts as back up for ... Job Title : Quality Assurance (QMS) Production Lead FLSA...this position may be eligible for benefits and participation in a bonus program based on performance and company… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …(APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring and trending program )Contribute to developing and/or improvements to quality systems ... multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based...process validation activities in support of the commercial Carvykti program both within Legend but also externally with our… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program . In this ... Communication, Entrepreneurship, Execution Excellence, Influence, Leadership, Networking and Partnerships, Program Management, Quality Management Systems (QMS), … more
- Merck & Co. (Ames, IA)
- … Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... Quality Management (SQM) and Animal Health global auditing program :ResponsibilitiesPerform comprehensive and detailed GMP compliance audits of animal health… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Rahway based Senior Specialist, Global Development Quality Operations, is responsible for independent approval of documentation to support GMP ... areas on requirements for all assigned project responsibilities as related to quality and our company's standards and communicate project status to management.Act as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the lives of more patients than ever before. The Position The Brand Strategy Lead is pivotal in developing brand level objectives and strategic priorities. They will ... Prioritizes phasing of objectives based on engagement objectives and sales forecasts. Lead the development and execution of annual and long-term brand planning Brand… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global regulatory ... development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions and will act… more
- Insmed Incorporated (NJ)
- …consistency, and operational excellence across all patient services functions. You will lead a team focused on monitoring program execution, identifying ... science, we're in. Are you?About the Role:The Associate Director, Patient Services Quality & Process leads quality assurance and process improvement initiatives… more
- Formation Bio (New York, NY)
- …to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug development ... internal and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the effective review and approval of batch… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into… more
- Applied Research Associates, Inc. (Alexandria, VA)
- …communication with senior DoW personnel and stakeholders + Risk mitigation and management + Lead program quality reviews + Identify and recommend process ... a motivated, energetic, and experienced **Critical Technologies Task Order Program Manager** to serve as ARA's task order ...Program Manager** to serve as ARA's task order program manager on the ARA's effort supporting the Assistant… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and ... Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical… more
- Merck & Co. (Rahway, NJ)
- …of contact for manufacturing leadership, engineering, commercial teams, supply chain, quality , IT, and external partners/vendors. Lead stakeholder engagement ... R5-equivalent - About the role We are hiring a Senior Product Manager to lead strategic development of our Integrated Printing and Plastic Manufacturing system - a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Insmed Incorporated (NJ)
- …with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for the company's small ... be a strategic leader, ensuring that development programs meet scientific, quality , regulatory, and commercial standards, while ensuring execution across internal… more
- Syner-G BioPharma Group (Boston, MA)
- …bring life-saving innovations to market faster, at scale, and with the highest quality . Our team partners with a diverse range of clients across the life ... provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to… more
- Merck & Co. (Montgomery County, PA)
- …budgeting, and launch readiness.Manage day-to-day operations of the patient support program , ensuring timely, high- quality patient interactions and case ... treatment for patients suffering with IBD.The marketing strategy role will lead foundational customer strategy and planning for a significant anticipated launch,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: Provides operational oversight to study management personnel within assigned program (s). Provides managerial oversight to colleagues that they are directly ... leading and ensuring delivery of milestones for the studies within assigned program (s). They are accountable to ensure their direct reports are delivering to… more
