- Novo Nordisk Inc. (Durham, NC)
- …process confirmation on shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & ... with the ability to train on Days. Relationships Manager, Quality Assurance . Essential Functions Ensure plant systems...root-cause analysis tools & techniques a plus Experience with Risk Assessment & Risk Management … more
- Novo Nordisk Inc. (Durham, NC)
- …process confirmation on shop floor Ability to support all processes & functions in Department Quality Risk Management Makes decisions on quality & ... & process confirmation on shop floor & improvement of Quality processes. Relationships Manager, Quality Assurance...root-cause analysis tools & techniques a plus Experience with Risk Assessment & Risk Management … more
- Insmed Incorporated (San Diego, CA)
- …with GTx Technical Operations and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. ... effectiveness of the Quality departmentAssist in other quality assurance related activities as agreed with management .Knowledge & Experience7+ years… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by the GQLs, EPQLs, and BPQLs, to internal and external stakeholders of R&D Quality .Support the oversight and management of CAPAs by tracking and following up ... of relevant quality reports and outputs (JOC, QRB, QQRs, EMR).CAPA Management Support the oversight and management of QE-related CAPAs by tracking… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately ... standards. This position is the decision maker for the Quality Management System deployed throughout the company....21 CFR part 4, and all associated regulatory requirements.Drive risk management in design, validation, and ongoing… more
- Formation Bio (New York, NY)
- …corrective and preventive actions (CAPAs) effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause analysis, ... bring new treatments to patients faster and more efficiently.About the PositionThe Director, Quality Management Systems plays a pivotal role in ensuring … more
- Tris Pharma (Monmouth Junction, NJ)
- …recommend/ implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and ... Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, ...Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product … more
- Twist BioScience (South San Francisco, CA)
- …Engineering, Biomedical or Biological Sciences, or a related field.10+ years of experience in quality assurance or customer service, with at least 5 years of ... We are seeking a highly experienced and motivated Staff Quality Engineer join our dynamic team. As a Staff...IVDRExperience with ISO 13485 and GMP requirements.Deep knowledge of Risk management and Design ControlExperience with Six… more
- Formation Bio (New York, NY)
- …corrective and preventive actions (CAPA effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause analysis, ... faster and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA...FMEA) and quality management software systems. Veev experience preferred. Strong organizational skills,… more
- Insmed Incorporated (San Diego, CA)
- …the Senior Director will be responsible globally for executing the safety and risk management activities. This individual is responsible for safety surveillance, ... risk management , and risk communication...other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance , Medical Affairs, Marketing, Manufacturing, and… more
