- Novo Nordisk Inc. (West Lebanon, IN)
- …records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records ... compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by...Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality… more
- Rhythm Pharmaceuticals, Inc (Boston, MA)
- …with internal and external stakeholders. Lead , develop, and mentor the clinical quality assurance team, responsible for the execution and sustainability of ... and our tenacity to overcome barriers, together.Opportunity OverviewThe Head, GCP Quality Assurance provides strategic leadership and direction for clinical… more
- Stirling Q&R Ltd (Sunnyvale, CA)
- …and key performance indicators Lead and mentor a team of quality assurance professionals Collaborate with cross-functional teams to address quality ... to patients. About the Role The Associate Director/Director of Quality Assurance will play a critical role...Drug Safety departments Prepare and review regulatory submissions for global health authorities Develop and implement quality … more
- Pulmonx Corporation (Redwood City, CA)
- …Affairs & Quality AssuranceThe Vice President, Regulatory Affairs and Quality Assurance implements regulatory strategies worldwide to 1) ensure that ... Affairs teams with respect to clinical studies involving Pulmonx products.Oversee the Quality Assurance team during facility inspections and audits of the… more
- Terns Pharmaceuticals, Inc. (Foster City, CA)
- …GIPR modulator program.Who We Are Looking ForThe Vice President, Regulatory Affairs and Quality Assurance , will lead the regulatory and quality ... This role will focus on developing and executing regulatory strategies, managing global health authority interactions, and overseeing quality operations to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or equivalent technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of the… more
- Merck & Co. (North Wales, PA)
- …Strong listening skills.Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance ) and the ability to be creative and ... review of the CMC Regulatory Strategy Document for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner ... CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global ... global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key global DS oncology early development initiatives. The Program Lead will have direct accountability for administrative deliverables, will interact regularly ... submission and compliance of all required DS documentation for quality control/ assurance , legal, finance, operational and educational requirements.Operates… more
- Meta (Menlo Park, CA)
- …a global and local level. We are seeking a strategic, analytical Quality Lead to inform leadership decisions, drive operational excellence, and elevate the ... dynamic and changing environment; and a passion for helping others achieve results. Quality Lead , Small Business Group Responsibilities:Manage the processes and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...team based in Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality … more
- Merck & Co. (Rahway, NJ)
- …efficient solutions.Define and enforce coding standards, development methodologies, and quality assurance processes.Drive innovation in SAP development ... revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component...the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all… more
- Merck & Co. (North Wales, PA)
- …the decision. Operate with Integrity and ensure adherence with organization policies, quality assurance and data protection processes.Conduct innovation proof of ... dynamic, innovative individuals dedicated to advancing our company's contribution to global medical innovation by leveraging information and technology.-One of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA… more
- Ramboll Group A/S (Seattle, WA)
- …and standards of scientific study, field investigation, sampling, experimentation, quality assurance of chemical measurements, research, and ... opportunity. Join our Health Sciences Spearhead as our new Lead Consultant and work with us to close the...back to laboratories if there are issues with data quality .Experience preparing project specific quality assurance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous… more
- MTX Group (Seattle, WA)
- …providing regular project updates, and resolving any issues that may arise.Oversee quality assurance to meet client standards and enhance satisfaction.Maintain ... risks to achieve project objectives and meet defined goals while maintaining MTX quality standards.MTX is a global technology consulting firm that enables… more
- Merck & Co. (Durham, NC)
- …or related disciplines with six (6) years of experience.Preferred Experience and Skills: Quality Assurance and/or cGMP experienceMinimum of 2 years managerial ... Job DescriptionThe Associate Director, Quality Technical, is responsible for leading a team...support the site product release program to include the following: Lead the team and others by providing direction and… more
- Takeda Pharmaceutical (Boston, MA)
- …across the global enterprise with key stakeholders (eg, in Research, Global Quality , Pharmaceutical Sciences, Plasma-Derived Therapies) to implement, as well ... of the archival function to ensure compliance to company quality standards and global regulatory requirements. The...success by employing deep expertise in archival sciences to lead the archiving strategy across the global … more
