- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... compliance with cGMP, regulatory expectations, and Insmed quality standards. Support inspection readiness and provide QC-related documentation and responses… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, ... investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility… more
- Sandoz Group AG (Princeton, NJ)
- …and personally. Join us as a Founder of our 'new' Sandoz! As the Associate Director , Market Product Quality you will be responsible for the execution ... Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Inspection Readiness , Leadership, Logical Thinking, Major Incident… more
- Bristol Myers Squibb (Trenton, NJ)
- …Read more: careers.bms.com/working-with-us . **Position Summary** Reporting to the Director , Inspection Readiness , the Associate Director will help ... and leaders across the BMS network. The Associate Director will support BMS' GMP/GDP Inspection Readiness strategy by supporting on-site and remote… more
- Lilly (Pleasant Prairie, WI)
- …driving solutions that impact the site and align with corporate objectives. The Associate Director , Quality Assurance, will also provide computer system quality ... to drive process improvements. This role ensures compliance and inspection readiness of the data integrity and...impact the site and align with corporate objectives. The Associate Director , Quality Assurance, will also provide… 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 ... of continuous GMP compliance in Regeneron and to build inspection readiness capability across the organization. This...each level: + Sr Manager - 8+ years + Associate Director - 10+ years May substitute… more
- GRAIL (Menlo Park, CA)
- …Grail's partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director , Clinical Compliance will play a key leadership ... to proactively manage both GCP and CDx regulatory risks, lead inspection readiness , and continuously improve quality standards utilizing insights… more
- Lilly (Pleasant Prairie, WI)
- …manufacturing, specifically the formulation/filling/ inspection of pharmaceutical products. The Associate Director will provide guidance on time management ... solutions to support communities through philanthropy and volunteerism. **Responsibilities:** The Associate Director TS/MS - Sterility Assurance is responsible… more
- Lilly (Pleasant Prairie, WI)
- …to make life better for people around the world. **Responsibilities:** The Associate Director , Validation is responsible for staffing, training, and leadership ... and the qualification of equipment, facilities, and utilities. The Associate Director may also provide input/guidance/oversight to...and Failure Modes Effect Analysis (FMEA). + Support site inspection readiness and execution. This role has… more
- Lilly (Concord, NC)
- …team operates, now is the perfect opportunity! During the project phase, the Associate Director (AD), Operations is responsible for staffing, training, and ... of the operations group supporting asset delivery, process development, operations readiness , start up, and validation of the parenteral operations (PAR) areas… more
- Pfizer (Pearl River, NY)
- …+ Support study team in issues resolution, study closeout, audit responses, inspection readiness , etc. **Supports the program team** + Under supervision ... country feasibility. **Support study team** + With supervision of medical monitor ( Director /Sr Director ) provides clinical input to protocol/study team for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …provide timely and high-quality clinical data that supports clinical study endpoints. ** Associate Director , Biomarker and Bioanalytical Operations** leads a team ... with cross functional teams including internal and external partners to ensure inspection readiness and support regulatory audits as needed + Serve as a vendor… more
- Merck (North Wales, PA)
- …and preparing for numerous potential launches of our medicines and vaccines. As Associate Director , Launch Excellence, you'll play an important role in preparing ... launch excellence subject matter expert. + Bring novel ideas to launch readiness across all strategic go-to-market launch components. + Drive transparency, … more
- United Therapeutics (Research Triangle Park, NC)
- …individual expertise and mentoring or developing a member of your team. The Associate Director , QA Engineering will provide advanced support and subject matter ... and manufacturing documentation, including complex data analysis, material specifications, inspection procedures, and manufacturing procedures, to ensure that the… more
- Lilly (Indianapolis, IN)
- …as we achieve drug product manufacturing and commercialization excellence. As the Associate Director of Technical Services/Manufacturing Science (TS/MS) in the ... cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction… more
- Lilly (Indianapolis, IN)
- …lead the charge in shaping the future of manufacturing at Eli Lilly? As an Associate Director of Engineering, you'll be at the forefront of this exciting ... cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction… more
- Lilly (Indianapolis, IN)
- …well as oversight of DS manufacturing at qualified collaboration partners. The Associate Director for Technical Services manages functional responsibilities for ... Pilot Plant and the organization remains in a state of inspection readiness + Ensures GMP compliance with environmental monitoring and campaign change-over… more
- Bristol Myers Squibb (Summit, NJ)
- …(global guidance documents, process control strategies, process risk assessments, etc), inspection readiness , and technical regulatory submissions. The Sr. ... Principal Engineer will support commercial product lifecycle management, including authoring of technical assessments and monitoring process performance including, but not limited to, continued process verification. The role collaborates across all CMC… more
- Lilly (Indianapolis, IN)
- …compliance with cGMPs, regulatory commitments, and Lilly Functional Standards; ensure inspection readiness . + Monitor product quality using metrics, CAPAs, ... and performance systems. + Build strong CM relationships to align on goals and expectations. + Lead validation strategy, protocol approval, execution, and reporting. + Manage change controls and assess regulatory/process impacts. + Investigate deviations,… more
