- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , ... QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... , audits and inspections, raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …direction and leadership for the investigations management system. Working closely with the Quality Senior Manager, this position will ensure alignment with all ... productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation… more
- Merck & Co. (Durham, NC)
- …and embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for ... Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …QA at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently ... the GPT, by interacting with other GxP QA functions ( GMP / IMP QA, Audit Compliance, Quality Management...impact. preferredAbility to effectively interact with and present to senior management at all levels, as well as to… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... manage & perform validation activities at the Boulder Pilot and Clinical GMP Plants. Handle simple to moderate complexity validation projects. Support engineers in… more
- Novo Nordisk Inc. (Boulder, CO)
- …raw materials and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Sumitomo Pharma (Columbus, OH)
- **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of ... currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP … more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill an Associate Director of Quality Auditing position. This position will be responsible for providing professional expertise, ... leadership, oversight and planning for the Regeneron Quality Auditing function, with primary emphasis on GMP...and communicating auditing Right to Operate (RTO) metrics to senior management + Ensuring the training and qualification program… more
- ThermoFisher Scientific (Cambridge, MA)
- …network (over 1200 colleagues across a variety of Quality sub functional roles). The Sr . Director Quality will champion and pursue world class quality ... North America (NA) Drug Product Division (DPD) is a senior level leadership role responsible for providing outstanding leadership...in the North America Leadership Team. **Key Responsibilities:** The Sr . Director Quality will be… more
- Lilly (Indianapolis, IN)
- …Development, or Administration is desirable. Additional Information: + Must complete ITP for Sr Director TS/MS. + No certifications required. + Tasks require ... better for people around the world. **Organization Overview:** The Sr . Director - TS/MS provides technical leadership...+ Assure API EM manufacturing processes adhere to Lilly quality expectations and stay current with ICH GMP… more
- Taiho Oncology (Pleasanton, CA)
- …except for Japan and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs Strategy is responsible for strategic ... Sr . Director , Regulatory Affairs Strategy Pleasanton,...and Europe. Position Summary: The incumbent is the most senior regulatory person on project teams and is responsible… more
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... and manage a diverse range of projects simultaneously. + Experience with quality by design (QbD), process validations and statistical design of experiments (DOE)… more
- Lilly (Durham, NC)
- …North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Sr Manager for QA Visual ... operations at Research Triangle Park Parenteral Manufacturing facility. The Sr Manager assists the Associate Director -QA Parenteral...regulatory inspections. + Review and / or redline to GMP documents ensure quality attributes are met.… more
- University of Utah (Salt Lake City, UT)
- Details **Open Date** 11/02/2023 **Requisition Number** PRN36805B **Job Title** PET Radiochemist, Sr . **Working Title** PET Radiochemist, Sr . **Job Grade** UGR ... Until Filled** Yes **Job Summary** Performs development, manufacturing, and quality control to support production of clinical and research radiopharmaceuticals… more
- Lilly (Concord, NC)
- …this role will transition to providing leadership, daily support, and oversight of GMP operations. The Manager, Quality Assurance will develop the quality ... programs to support GMP manufacturing. The Manager, Quality Assurance will assist with developing the training program...daily work of QA personnel. Responsibilities: The Night Shift Sr . Manager, Quality Assurance, will support the… more
- ThermoFisher Scientific (Allentown, PA)
- …hard every day knowing that what they do matters. **Discover Impactful Work:** The Sr Quality Manager is responsible for supporting, and at times leading, the ... improvement activities. + Provides leadership in promoting and enforcing GMP and company quality requirements. + Resolves...regulations. + Provides suggestions and improvement ideas to the Quality Director related to work related processes… more
