- Novo Nordisk Inc. (Durham, NC)
- …2:30am with the ability to train on Days. Relationships Manager, Quality Assurance . Essential Functions Ensure plant systems batch release & relevant quality ... processes are compliant with regulations Authority for product release Quality oversight, review & approval of validation activities associated with projects, new systems, changes to existing systems & maintaining validated state and performing archiving… more
- Novo Nordisk Inc. (Durham, NC)
- …shop floor & improvement of Quality processes. Relationships Manager, Quality Assurance . Essential Functions Ensures plant systems batch release & relevant quality ... processes are compliant with regulations Has product release authority Quality oversight, review & approval of validation activities associated with projects, new systems, changes to existing systems & maintaining validated state Presentation, support &… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Manager has responsibility for the QA oversight of manufacturing build ... the overall effectiveness of the Quality departmentAssist in other quality assurance related activities as agreed with management.Knowledge & Experience7+ years… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately ... responsible for the product quality received by the customer and the quality system integrity expected by the customer. The Quality Director is committed to relentlessly pursuing zero defect manufacturing and maintaining strong and efficient conformance to all… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's ... for trials. Establish and maintain 'fit for purpose' GMP related quality assurance procedures processes, and documentation to ensure the consistent production of… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Director, DSPV Gene Therapy Safety Lead will be the safety expert ... knowledge of the assigned product portfolio and safety profiles for products. The Senior Director will be responsible for the day-to-day direction to ensure business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in Raritan, NJ. Role OverviewThis position will be ... aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and FDA/EU… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working ... knowledge of reporting processes (SOPs) and software development life cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.Experience assuring programming… more
- Aequor (Thousand Oaks, CA)
- …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 project management skills.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality Control departments to ... complete the technology transfer for customers. This position will lead, mentor and grow the Technical Service Department.Job ResponsibilitiesFunction as the customer liaison for tech transfer projects.Forest customer service throughout the organization and to… more
