- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Novo Nordisk Inc. (Boulder, CO)
- …worlds to develop new medicines for patients. The Position Novo Nordisk is seeking a Quality Control Manager to support the successful start-up of the Quality ... that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the ... quality and process validation requirements for existing products. Participate...Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency auditsEnsure site/system validation program meets… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T ... implement process improvements related to investigations cycle time, closures, quality , and compliance.Develop strategies to increase investigations output while… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary The Study Associate Manager , under the guidance of the Associate Director, will supervise a group ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....relationships may include Convention Marketing and Sales Training. The Manager may represent Medical on PRB working group, brand… more
- Merck & Co. (Durham, NC)
- …product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will ... The focus for the position includes all aspects of Quality oversight for drug substance, media preparation, and sterile...objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...a licensed drug or biologic facility regulated by the FDA , EMEA or a leading international regulatory agency preferred… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, cGMP, ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk ... vendor relationships and governance, holding external partners to high standards of quality , cost control, and on-time deliverables. Serve as the Operations Lead for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceutical. Experience in supporting ... Legend Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Lab Oversight Specialist role is… more
- Novo Nordisk Inc. (Durham, NC)
- …Address any safety, quality , staffing or personnel issues & escalate to manager as may be necessary Monitor performance & completion of training to ensure the ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...scheduling experience for this area is a plus. Relationships Manager . Essential Functions Execute production plans by leading the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... to realize your potential? The Position This position provides support for technical, quality , and project issues related to automated systems at our biologics based… more
- Actalent (Longmont, CO)
- Job Title: Quality ManagerJob Description We are seeking a dedicated Quality Manager to develop and maintain a quality management system that complies ... quality management system in compliance with ISO:2016 and FDA regulations. + Conduct internal and external quality... FDA regulations. + Conduct internal and external quality audits to ensure adherence to regulatory standards. +… more
- Actalent (Longmont, CO)
- Actalent is hiring a Quality Manager ! Job Description Develop and maintain a quality management system compliant with ISO 13485 and FDA regulations. ... quality management system compliant with ISO 13485 and FDA regulations. + Conduct internal and external quality... FDA regulations. + Conduct internal and external quality audits. + Manage the supplier quality … more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …to ensure compliance with all regulatory requirements. The estimated pay scale for the Quality Assurance Technical Manager role based in Los Angeles, CA, is $95k ... and regions. _Job Summary:_ Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation… more
- Walgreens (Deerfield, IL)
- **Job Description:** **Job Summary** The Manager , Pharmacy Quality Assurance & Patient Safety ensures pharmacy policies and procedures are followed in order to ... adherence to FDA mandated programs. To ensure implementation of all Quality Assurance programs, policies, and procedures to provide optimal patient care and… more
- Unilever (Austin, TX)
- …we'd love for you to be part of it. **About the Job:** The Quality Assurance Manager is responsible for overseeing and continually enhancing the organization's ... quality systems, ensuring full compliance with applicable ...training, change control, CAPA, deviations, and complaint handling. The Quality Assurance Manager is instrumental in upholding… more
- Amneal Pharmaceuticals (Brookhaven, NY)
- …, Regulatory Compliance, supports with establishing new, revising and maintaining Global Quality Standards current. The Manager , Regulatory Compliance, has a ... Description: The Manager , Regulatory Compliance, assembles a team for site-wise...direct interface with Site Quality Heads and Functional Heads with respect to FAR… more
