- Legend Biotech USA, Inc. (Raritan, NJ)
- …Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, ... development of validation and qualification related policies, procedures, templates, formsProvides quality oversight on data integrity of systems, instruments,… more
- Merck & Co. (Durham, NC)
- …First Time" mindset. Consistently deliver On-Time and In-Full - with First Pass Quality . Oversight and presence on the production floor at External Partner ... Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our relationship with External Partners that manufacture, assemble, and test… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Oversight : Manages higher-level negotiation with external vendors. Provides oversight of quality /performance and budget, resources and timelines across ... the department and ensures timely delivery of high- quality deliverables at reasonable cost. Provides documented oversight of the external vendors/sponsor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …against service level and KPIs.Manage the development of governance, business continuity, quality , and vendor monitoring plans. Maintain oversight for capability ... agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that are PV relevant and AE reporting language… more
- Aequor (Thousand Oaks, CA)
- …experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, ... who are proactive, able to work independently with minimal oversight , and comfortable escalating issues appropriately. Candidates seeking long-term opportunities… more
- Formation Bio (New York, NY)
- …timelines, budgets, and resources across biologics programs; ensure delivery of high- quality milestones on schedule. Technical Oversight Provide scientific and ... in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and execute… more
- BioSpace (Washington, DC)
- …us and transform the lives of patients while transforming your career. Sr Manager Quality Assurance, Device Supplier Management and Oversight What you will do ... assigned critical external mechanical device suppliers. Lead a team of quality professionals overseeing external mechanical device suppliers Ensure compliance with… more
- Voyager Therapeutics (Lexington, MA)
- …the following: Final Release of product, including use of QPs for ex-US release. Quality oversight of external and internal GMP manufacturing and QC. GxP ... compliance; including Training, Deviation and change control. CRO and CDMO Quality Oversight including qualification and audits. Internal auditing and inspection… more
- AltaMed Health Services Corporation (Montebello, CA)
- …that support Star measures, HEDIS, pay-for-performance initiatives, and other quality oversight functions. Major responsibilities include processed data ... community clinic can deliver, we demonstrate our belief that quality care is for everyone. Our commitment to providing...that drives us forward every day. Job Overview The Quality Specialist is a California licensed nurse responsible for… more
- BioPharma Consulting JAD Group (Cambridge, MA)
- …Assurance is a key member of the GVP QA team, providing global quality oversight of post-marketing pharmacovigilance systems. This includes ensuring compliance ... the GVP audit program and inspection readiness initiatives. Key Responsibilities: Provide quality oversight of global pharmacovigilance (PV) systems and ensure… more
- AbbVie (North Chicago, IL)
- …of the R&D Quality Medical Affairs (MA) QA team which provides independent quality oversight of AbbVie's Medical Affairs and Health Impact (MHI) function and ... delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues...have a remarkable impact on people's lives. As a quality organization in research & development, R&D Quality… more
- SpringWorks Therapeutics (Raleigh, NC)
- …maintain QA PV Standard Operating Procedures (SOPs) and Work Instructions (WIs). Provide Quality oversight for PV related documents, including SOPs and WIs. ... Provide Quality oversight for PV deviation and CAPA program. Lead process improvement projects as needed. Stay current with new and revised regulations and… more
- Eisai, Inc (Nutley, NJ)
- …phases.The VP of Global Clinical Operations is responsible for the management, oversight , and direction of the clinical operations function in the execution of ... all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This individual must effectively… more
- Phlow Corp (Petersburg, VA)
- …Manager of Quality Assurance is responsible for planning, managing, and tracking quality documentation, and having quality oversight of the operation of ... teams (RA, Operations, IT, MST, etc.) to bring excellence in quality oversight and operational execution all Phlow products. Requirements *Support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provides strategic leadership in Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance ... of group members. This position also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and leads the execution for… more
- Takeda Pharmaceutical Company Limited (Latham, NY)
- …routine tasks according to SOP through direct observation. Plasma Collection Center Quality Assurance Oversight : (80%) Reviews operational records to ensure they ... consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Authorized… more
- Merck & Co. (North Wales, PA)
- …and study design, analysis strategy, and analysis results with highest quality . This individual is responsible for hiring appropriate, qualified staff, coaching ... and employee development. Additionally, the AVP may provide strategic oversight and sponsorship of departmental initiatives.The requirements for this role… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.The Sr. Specialist, Calibration… more
- Merck & Co. (Durham, NC)
- …a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while ... reliably supplying quality product at a competitive cost consistent with our...by policies, procedures and business plan; receives guidance and oversight from Operations Associate Director and Director;Interprets client and/or… more
