- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities This individual with provide direct support to the Director of Manufacturing Excellence by providing technical expertise to Technical ... to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the establishment and … more
- Genmab (Plainsboro, NJ)
- …GCDS Operations projects within the area of clinical drug supply management .Oversee inspection readiness and ensure compliance with relevant regulations.Manage ... a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, Denmark.Main Responsibilities IncludeEngage with… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill an Associate Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive ... activities that will ensure a state of continuous GMP compliance in Regeneron and to build inspection...and ensure we are performing with in compliance. The Director will also provide support during regulatory inspections and… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Sr/Executive Director , GMP Data Governance & Integrity position within our Quality Assurance organization. This position is ... responsible for the Regeneron GMP Data Governance and Integrity program. Directs and leads...a culture of documenting processes + Works with department management to build a robust data governance program, champion… more
- Novo Nordisk (Clayton, NC)
- …required + Minimum of three (3) years progressively responsible experience in material management &/or GMP quality, required + Experience in one or more ... interest in ensuring high quality raw materials for Novo Nordisk US. Relationships Director , US Sourcing Hub. Essential Functions + Responsible for raw materials &… more
- Lilly (Indianapolis, IN)
- …for quality inspectors, operators, and other relevant staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements. + Mentor ... to those who need them, improve the understanding and management of disease, and give back to our communities...is preferred). + 10+ years of experience in visual inspection for injectable pharmaceutical products in a GMP… more
- Bristol Myers Squibb (Indianapolis, IN)
- …across the organization to support the development, continuous improvement and lifecycle management of GMP policies and procedures. + Provide leadership and ... agency inspection experience required. + Experience implementing and improving GMP Quality systems related to commercial manufacturing operations is required +… more
- BD (Becton, Dickinson and Company) (Sumter, SC)
- **Job Description Summary** The Plant Associate Quality Director serves as the Plant Management Representative and as a member of the site leadership team with ... your best self. Become a **maker of possible** with us. The Plant Associate Quality Director serves as the Plant Management Representative and as a member of the… more
- Lilly (Pleasant Prairie, WI)
- …ensures compliance and inspection readiness of the data integrity and data management program at the site level. The Site Data Leader is responsible for ensuring ... improvement. Lead initiatives related to data integrity and data management for GMP information at the site:...inspection readiness of the data integrity and data management program at the site level: + Coach individuals… more
- Astellas Pharma (Sanford, NC)
- **Quality Assurance, Site Leader (Senior Director )** Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies ... our journey. Astellas is announcing a **Quality Assurance Site Leader (Senior Director )** opportunity at their **Astellas Gene Therapy (AGT)** site in **Sanford,… more
- ThermoFisher Scientific (Greenville, NC)
- …domestic and global regulations and corporate policies. Provides on-site support for inspection management for key inspections. Ensure compliance to all ... For more information, please visit www.thermofisher.com . **Position Summary:** The Sr. Director will ensure that the overall cGMP compliance profile is maintained… more
- Curia (Albuquerque, NM)
- … GMP areas and responsibilities are maintained in permanent inspection -ready state + Ensure timely identification, investigation, correction, and resolution of ... Director , Quality Operations, Albuquerque, NM Curia provides global...model + Ensure appropriate support of operations including in-process inspection , final product inspection , in-process (real-time) batch… more
- Lilly (Durham, NC)
- …the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection . The Associate Director will help build a strong ... make life better for people around the world. Associate Director Quality Assurance (QA) Parenteral is responsible for the...for metrics reviews, operational support, and issue / deviation management + Review and approve GMP documentation… more
- Lilly (Durham, NC)
- …team for metrics reviews, operational support, and issue / deviation management + Review and approve GMP documentation including qualification/validation ... to those who need them, improve the understanding and management of disease, and give back to our communities...make life better for people around the world. Associate Director - Quality Assurance (QA) Packaging is responsible for… more
- Abeona (Cleveland, OH)
- The Associate Director Quality Control (QC) will lead QC activities associated with the GMP production. Such products include Adeno-associated Viral Vectors ... oversee the operation of the QC Microbiology and Transport functions. The Director is responsible for supporting the QC testing, utility and environmental monitoring… more
- Astrix Technology (Indianapolis, IN)
- **Associate Director of Quality Assurance** Manufacturing Indianapolis, IN, US Pay Rate Low: 150,000 | Pay Rate High: 180,000 + Added - 16/01/2025 Apply for Job ... **_Leading Biotechnology Research company is hiring for an Associate Director of Quality Assurance to_** **_oversee quality systems within GMP manufacturing of… more
- ALDI (Batavia, IL)
- …of private label products, is seeking a dynamic leader to fill the role of Director of Food Safety and Quality Assurance. This is your chance to spearhead the ... quality strategies that will shape the future of our organization. As the Director , you'll have the opportunity to drive innovation, maintain rigorous standards, and… more
- OnKure, Inc. (Boulder, CO)
- …position in Quality Assurance provides strategic and technical support of the Quality Management System (QMS) and is responsible for ensuring GxP and QMS compliance. ... operations goals. The ideal Quality Assurance candidate will have small-molecule, development-phase GMP experience, and also have a strong desire and proven ability… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …the program. Through outstanding communication, effective problem solving and active management of ambiguous situations, the Director , Compliance Programs ... to address some of the most challenging global health issues. The Director , Quality and Regulatory Compliance, Compliance Programs is responsible for helping to… more
- Teva Pharmaceuticals (North Wales, PA)
- …participation in US Commercial activities. + Ensures operational implementation of Quality Management System in compliance with GMP &GDP and Teva Corporate ... Director Commercial Quality US Date: Feb 12, 2025...and associated resources, compliance activities including complaints and recall management , regulatory event reporting, drug shortage reporting, Health Authority,… more
