- Daiichi Sankyo, Inc. (Bernards, NJ)
- …participation in relevant training programs.Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance.Keep ... areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA ) ensures high standards of… more
- Merck & Co. (Rahway, NJ)
- …strategic partnerships with manufacturing sites and partner groupsRegulatory Compliance and Quality Assurance :Ensure that all activities are conducted with the ... and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a team… more
- 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
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Director , QA Validation ( Drug Product) position. This position leads department responsible for Drug Product ... with regulatory requirements + Responsible for all aspects of QA Validation including review and approval of...At least 5 + years experience specifically in a validation / quality assurance function and managerial… more
- Fujifilm (College Station, TX)
- …**:** Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking ** Quality Assurance ( QA ) Validation - Associate Director ** to oversee the review and ... team. **Job Title:** Quality Assurance ( QA ) Validation , Associate Director **Reports...Strong understanding of cGMP regulations for the production of drug , biologics, or vaccine products. + Excellent written and… 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
- 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
- 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …participation in relevant training programs. + Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance. + Keep ... immune disorders. **Summary** The Sr. Director , Data Quality and Integrity (Global R&D & PV QA...that technology-related audits are conducted. + Oversee and guide quality assurance processes related to project specifications,… 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
- Catalent Pharma Solutions (Harmans, MD)
- ** Director , Quality Assurance Clinical Operations** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing ... AAV and other viral vector-based therapies and vaccines. The Director , Quality Assurance Clinical Operations...real-time batch record review, QA -OTF support, client-facing QA activities, and deviations management. The Director … more
- Lilly (Durham, NC)
- …to make life better for people around the world. Associate Director - Quality Assurance ( QA ) Packaging is responsible for the staffing, training, and ... leadership of the quality assurance group supporting the project/expansion delivery,...Associate Director will help build a strong quality culture and lead the QA team… more
- Fujifilm (College Station, TX)
- …will include one or more PQS sub-system: Deviation, CAPA, Change Control, Supplier Quality , Training, Document Control, QA Validation , eQMS, and ... **Position Overview** The Director Quality Systems is responsible for...Quality + Training + Document Control, eQMS + QA Validation + Quality management… more
- Novo Nordisk (Bloomington, IN)
- …Records, technical transfer, and process characterization reports + Responsible for representing Quality Assurance as the primary contact for assigned projects, ... make what matters. About The Position Relationships Reports to Manager or Director Essential Functions + Collaborates with Quality Control, Materials Management,… more
- Fujifilm (College Station, TX)
- …improvements, and acting as a QA liaison internally and externally. **Reports to** Director , Quality Assurance /Senior Manager, Quality Assurance ... **Position Overview** The Quality Assurance ( QA ) Analyst...approval + Drug Substance/Product Reports + Trending QA data + Draft and review internal Quality… more
- Novo Nordisk (Bloomington, IN)
- …initiatives, and process validation activities. The Position Relationships Reports to: Director , QA Essential Functions Quality Systems and Metrics + ... drug products for our clients and their patients. Quality Assurance Systems group has ownership over...of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations… more
- Lilly (Durham, NC)
- …Specialists, while reporting directly to the Associate Director - DAP and Warehouse Quality . The Quality Assurance Floor Supervisor provides support and ... make life better for people around the world. The Quality Assurance Floor Supervisor is responsible for...quality and operational issues. Escalates issues to Associate Director - DAP and Warehouse QA , when… 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
- Charles River Laboratories (Northridge, CA)
- …to establish and maintain compliance; including responsibilities associated with the quality assurance tasks. Essential Responsibilities + Perform job functions ... of suppliers performing collections. The position works closely with QA management staff, the Medical Director , Operations...support the Quarterly Management Review meetings. + Assist other QA staff with regulatory and quality functions… more
