- Merck & Co. (Durham, NC)
- … Quality Auditing, Quality Control Documentation, Quality Control Management , Quality Management Systems (QMS), Quality Metrics, ... Job DescriptionThe Quality Associate Director/GMP Lead Site Auditor...required with site leadership, regional compliance leadership and Divisional Quality Assurance to elevate site audit program … more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:We're looking for a Quality Management System (QMS) Specialist on the Analytical Development team to help ... the Technical Operations department. You will be responsible for managing the Quality Management System (QMS) for the entire Technical Operations department.What… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsible to complete on paper basis audit and to monitor vendor performance management program . Support the issue and communication of audit plans, agenda ... documents that set strategy in QA GMP Audit processes for contribution of Quality Management System (QMS) establishment processes in collaboration with GMP … more
- Formation Bio (New York, NY)
- …driving near-term development milestones until steady-state ownership is established.Key ResponsibilitiesDiligence Program Management Lead and manage the ... faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director, Program Management - Asset Diligence & Integration to partner with… more
- Novo Nordisk Inc. (Boulder, CO)
- …Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance. The Technical Team Lead , API Manufacturing acts as a ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Merck & Co. (Rahway, NJ)
- …Devices Design, Negotiation, Process Manufacturing, Product Design, Production Process Development, Project Management , Quality Management Systems (QMS) {+ 4 ... to set tactical and strategic direction on programs they lead to ensure high quality products and...development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and… more
- Cipla (Fall River, MA)
- …8:30 AM - 5:00 PM (may vary based on business needs) Reports To : Quality Assurance Manager Salary Range: $62,400 - $75,400 (DOE) Purpose: This position requires a ... not limited to the following: Scope : The Analytical Quality Assurance (AQA) associate I position is an team...some weekends based on business needs as required by management . Relocation negotiable. No remote work available. This role… 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
- Formation Bio (New York, NY)
- …the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug development capabilities. ... and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of… 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)
- …are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program . This role will ... cloud security, and identity management .Skilled in budget planning, vendor management , and strategic program delivery .Proven track record of driving… more
- Formation Bio (New York, NY)
- …and clinical studies. Collaborate with cross-functional teams (Clinical Development, Regulatory, Program Management , etc.) to shape and refine Clinical ... faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical… more
- Insmed Incorporated (NJ)
- …in. Are you?About the Role:We're looking for a Senior Manager, Supplier Relationship Management on the Global Supply Chain & Logistics - Supplier Relationship ... Management team supporting the Technical Operations organization to help...and internal cross-functional stakeholders across disciplines of Manufacturing, CMC, Quality , Legal, Procurement and Finance. The ideal candidate would… more
- Insmed Incorporated (NJ)
- …safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information. Lead the Safety ... of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products. Lead the identification of risks and appropriate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on documentation compliance, audit results, and improvement initiatives to senior management Lead continuous improvement initiatives related to GxP documentation ... Vendor Oversight. This job will interact with Patient Safety, Quality , Vendor and Contract Management , IT, Finance,...Programs, and other CMR Functional areas. This job will lead a team of Patient Safety training and vendor… more
- Insmed Incorporated (NJ)
- …and procedures. Ensure compliance with all Company/Regulatory requirements & TMF quality standards.Work with outsourcing/procurement management to optimize the ... can be hybrid or remote.What You'll Do: Primary operational lead over an 1-2 indications within one compound, in...staff and to project teams for vendor evaluation, selection, management and quality -based oversight.Responsible for the … more
- Aptyx (Charlotte, NC)
- …department's objectives to provide goods and services that meet customer requirements for quality , quantity, and timeliness. The primary role of an R&D Engineer is ... to lead project deliverables and lead technical reporting...successful conclusions. DUTIES AND RESPONSIBILITIES Responsible for following the Quality system, including all applicable SOPs included in the… more
- Cipla (Fall River, MA)
- …management committee, commercial, portfolio, R&D technical staff, supply chain management , medical affairs, regulatory affairs, quality assurance, procurement ... Cipla is a leading global pharmaceutical company, dedicated to high- quality , branded, and generic medicines. We are trusted by...contributor role that reports to the Director of Project Management , R&D, North America. The job duties for this… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with us? The Position The Director, Key Opinion Leader Strategy & Engagement will lead a team and critically shape KOL strategy & engagement across NN USO. They ... KOL- and association-related brand/therapy area strategic objectives KOL Experience Strategy: Lead the execution of KOL experience strategies and ensure transparent… more
- Cipla (Fall River, MA)
- …new technologies and automation in production workflows. Collaborate with Team, Quality , Supply Chain, Project Management , Engineering, and R&D teams ... Monitor packaging processes for adherence to cGMP, FDA, and Cipla's quality standards. Identify and resolve operational inefficiencies, escalating complex issues… more
