- 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... Quality department.Assist in other quality assurance related activities as agreed with management .Job… 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 ... accurate, and documented according to written procedures and cGMP requirements. Alert management of quality , compliance, supply and safety risks. Complete… more
- Antares Pharma (San Diego, CA)
- …status quo, advancing our mission and making our One Team culture thrive.Join us as an Associate Director, External Quality Assurance and you'll be part of a ... delivers meaningful innovations that impact people's lives.How you will make an impactAs the Associate Director, External Quality Assurance , you will lead … 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 ... GxP Quality Management System and Compliance activities related...report review, evaluating responses, and closure of audits.Provide GMP Quality Assurance oversight of products manufactured at… 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 ... and compliance throughout the organization. Key Responsibilities Develop and maintain quality management systems in compliance with cGMP, GLP, and other… 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
- Rakuten Medical Inc. - US (San Diego, CA)
- …company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, ... preferred. Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance. Minimum of...Part 11 compliance is a plus. Experiences with Clinical Quality Management on a risk-based approach is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of ... the Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level position… 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...activities with department objectivesFUNCTIONAL EXPERTISE:Specific to Technical Support, the Associate Director will be responsible for comprehensive management… 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 ... mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow and implement instructions. Written and… more
- Merck & Co. (Rahway, NJ)
- …holder through the entire product lifecycle.Key areas of focus include:the assurance of deliverable quality and process compliance,effective deliverable ... industry best-practicesExperience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Ability to… 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)
- …the decision. Operate with Integrity and ensure adherence with organization policies, quality assurance and data protection processes.Conduct innovation proof of ... Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use of these Data Assets.--This role… 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 ... reviewing proposals and selecting vendors. This position also supports the management of the WO development and implementation.Supports packaging design and patient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative 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… more
- Merck & Co. (North Wales, PA)
- … 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
- 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 ... to convert complex ideas and information into simple readable form.Strong project management skills; Manage at a program level; influences approach/s and ensures… more
- Xenon Pharmaceuticals Inc. (Boston, MA)
- …key internal stakeholders such as Finance, Clinical Operations, Regulatory Affairs, and Quality Assurance . This position reports to the Senior Director, Supply ... conducting audits and identifying trends that may indicate problems with data quality , and;Designing and implementing data management policies and procedures to… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …Science for drug substance and drug product development, GMP Quality Assurance , in addition to Project Management , Clinical Operations, Clinical Supply, and ... 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
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