- Eisai, Inc (Exton, PA)
- …cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation , and other internal ... will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program… more
- Merck & Co. (Rahway, NJ)
- …members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance :Ensure that all activities are conducted with the ... with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead...risk analysis, control strategies, design verification testing, and process validation , with a strong understanding of quality … more
- Eli Lilly and Company (Indianapolis, IN)
- …operational excellence. The Sr. Director - DSCSA Compliance & Manufacturing Logistics Quality Assurance , is a Quality professional with expertise in GMP ... world. We are seeking a strategic and experienced Senior Director of Drug Supply Chain Security Act... quality assurance and DSCSA compliance. The Sr. Director … more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …Procedures (SOPs) for all Clinical Pharmacokinetic-related studies Work with the Quality Assurance team on SOP development, revision, and implementation. ... We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's...follow us on LinkedIn and X. Position Summary The Director of Clinical Pharmacology will play a pivotal role… more
- Thermo Fisher Scientific (Greenville, NC)
- …Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Position: Director , Manufacturing Science and Technology (MSAT) Reports To: Site Vice ... NC How will you make an impact? The MSAT Director provides scientific leadership to ensure compliance, resilience &...Subject Matter Expert (SME) in Large and Small Molecule Drug Products and directs a team of Molecular Biologists,… more
- Eli Lilly and Company (Indianapolis, IN)
- …Controls to support the Resin Management programs where necessary. Liaise with Quality Assurance to ensure microbiological controls are considered in the ... functions but will be coordinated by the Ramp Team Sr. Director . Key Objectives/Deliverables: Responsible for the development, implementation and establishing… more
- The Ohio State University (Dublin, OH)
- …of software and hardware, end user training and support, guidance and assistance with validation and quality assurance of images. The Clinical Laboratory ... Technical and medical activities are in coordination with Chair of Pathology, the Director of Anatomic Pathology and the Director of Surgical Pathology. Duties… more
- Catalent Pharma Solutions (Greenville, NC)
- …capabilities, ideal for orphan or targeted drug development. The Associate Director , Commercial Quality Assurance provides leadership and support in ... **Associate Director , Commercial Quality Assurance **...change control. + Demonstrated experience leading Quality Assurance teams in commercial manufacturing QA to… more
- Fujifilm (Holly Springs, NC)
- …for you to lead and grow in a world-class Quality organization as the Director , QA Drug Substance Operations. In this role, you will oversee our ... **Position Overview** ** Director , QA Drug Substance...Engineering, Validation , and Automation + Ensures the quality assurance ( QA ) review and… more
- Lilly (Pleasant Prairie, WI)
- …solve problems both locally and across global M&Q. Act as the Computer systems validation quality assurance project lead, working with Global Facility ... the site and align with corporate objectives. The Associate Director , Quality Assurance , will also...+ Minimum 3 years of experience in Computer System Quality Assurance /Computer System Validation +… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems...needs of the business while maintaining a focus on quality and information assurance . + Solid knowledge ... Engineer Summary: The Senior QA Validation Specialist - CSV Systems Engineer...to date trainings + Other duties as assigned by QA manager and/or QA director … more
- OnKure, Inc. (Boulder, CO)
- Position Description: This position in Quality Assurance provides strategic and technical support of the Quality Management System (QMS) and is responsible ... compliance with regulatory, clinical, and business operations goals. The ideal Quality Assurance candidate will have small-molecule, development-phase GMP… more
- Gilead Sciences, Inc. (Foster City, CA)
- …will improve the lives of patients with life-threatening illnesses worldwide. As an Associate Director of Quality Assurance , you are responsible for: **Job** ... field with 8+ years of relevant experience. * Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug… more
- Lilly (Branchburg, NJ)
- …to make life better for people around the world. Eli Lilly and Company seeks a Quality Assurance Associate Director (M2) to provide quality direction for ... a related STEM field followed by 5 years of progressively responsible experience with quality assurance or quality control in the pharmaceutical or… more
- Lilly (Indianapolis, IN)
- …for people around the world. #WeAreLilly **Responsibilities:** The Associate Director - Quality Assurance ( QA ) is responsible for managing the activities ... environment in any of the following associated disciplines: TSMS, Production, Quality Assurance , Quality Control, Engineering, Project Management,… more
- Novo Nordisk (Bloomington, IN)
- …high quality drug products for our clients and their patients. Quality Assurance Systems group has ownership over the quality systems, including ... well as oversight of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight… more
- PCI Pharma Services (Madison, WI)
- …QA Manager is responsible for oversight of all daily functions of the quality system. Directly Supervise Documentation Control, QA Associates and Trainer, and ... may be assigned. + Work directly with the Sr. Director , Quality on continuous improvement activities. +...ensuring that client specifications are met during materials receipt, Drug / Device processing and final product shipment. +… more
- Lilly (Indianapolis, IN)
- …functions but will be coordinated by the Ramp Team Sr. Director . **Key Objectives/Deliverables** **:** Responsible for the development, implementation and ... Support new site TSMS cleaning teams on developing Cleaning Validation Master Plan for the facility, using expertise and...the development a training program/education for TSMS, Process Engineering, QA and Ops based on the Cleaning Process with… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …related to downstream processing. + Collaborate closely with Upstream MSAT, Validation MSAT, QA , Regulatory, Process Development, Analytical Development, and ... **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes… more
- AbbVie (Waltham, MA)
- …driver for the quality and compliance + Develops Global Product Quality Assurance strategy and implements agreed strategy to support pharmaceuticals, ... impact to timelines, resources and conflicting priorities. + Manages team interfaces with Quality Assurance audit team to develop audit plans, due diligence… more
