- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director, Quality Assurance - Analytical,GMP has ... other departments to increase the overall effectiveness of the Quality department.Assist in other quality assurance...effectiveness of the Quality department.Assist in other quality assurance related activities as agreed with… more
- Aequor (West Greenwich, RI)
- …7:00 PM Job Details: In this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support of Manufacturing activities. This position ... bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. Responsibilities Include the Following: Provide… 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 ... in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the Quality … 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 that supports deviation management, change control, site… more
- Merck & Co. (Durham, NC)
- Job DescriptionJob DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored ... and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities,… more
- Aequor (Thousand Oaks, CA)
- …equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or ... medical device industry. Evaluate documentation and operation according to company guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic… more
- Precision Life Sciences (Boston, MA)
- Associate Director, Quality AssuranceThe Associate Director, Quality Assurance is accountable and responsible for the execution and oversight of the ... audit agendas, report review, evaluating responses, and closure of audits.Provide GMP Quality Assurance oversight of products manufactured at facilities, if… more
- Merck & Co. (Rahway, NJ)
- …holder through the entire product lifecycle.Key areas of focus include (1) the assurance of deliverable quality and process compliance, (2) effective deliverable ... industry best-practicesExperience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Ability to… 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 ... data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data...Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams, and supports change implementation. Coordinates with regional/global RACMC, Quality Assurance , Pharmaceutical Technology, and other functional areas ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC… more
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of ... risks is recognized and the need for CAPAs or reports on deviations is clearly understood. Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address such… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and Global IT functions of Daiichi Sankyo. As a trusted partner, provide oversight of technical and… more
- Merck & Co. (North Wales, PA)
- …opportunities arise; ability to engage key stakeholders.Demonstrated success in the assurance of deliverable quality and process compliance.Familiarity with ... statistics and clinical data management concepts. Preferred Experience and Skills: Strong working knowledge of reporting processes Standard Operating Procedures (SOPs) and software development life-cycle (SDLC).Provide technical and/or programming guidance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years of professional experience within the pharmaceutical industry working within Quality Assurance is required.Must have a broad understanding of ... R&D PV QA organizational strategy. This position will proactively collaborate with other Global quality colleagues to drive the global QA vision and act as the US QA… more
- Stirling Q&R Ltd (Sunnyvale, CA)
- …their team and help bring life-changing treatments to patients. About the Role The Associate Director/Director of Quality Assurance will play a critical role ... metrics and key performance indicators Lead and mentor a team of quality assurance professionals Collaborate with cross-functional teams to address quality … more
- Kyverna Therapeutics, Inc. (Emeryville, CA)
- …is recruiting a highly motivated Associate Director, Patient Operations - Quality Assurance in its Technical Operations organization to help advance its ... assessments for any deviations associated with cell collection/processing centers.Represent Quality Assurance on cross-functional project teams, as… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and resolve basic to moderate operating difficulties.Collect required samples needed for Quality Assurance testing as required.Perform line changeovers in a safe ... distribution of pharmaceutical products in compliance with local Administration. The Manufacturing Associate will rely on experience and judgment in order to plan… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …with Pharmaceutical Science for drug substance and drug product development, GMP Quality Assurance , in addition to Project Management, Clinical Operations, ... position involves working closely with cross-functional colleagues including regulatory operations, quality , CMC, nonclinical and clinical team members. S/he will be… more
- Kyverna Therapeutics, Inc. (Emeryville, CA)
- …approved technical source documents in accordance with project timelines.Work in partnership with Quality Assurance and CMC teams to ensure adherence to Good ... how autoimmune diseases are treated.Kyverna is seeking an experienced and passionate Associate Director, CMC Regulatory Affairs with a strong background in cell and… more
