- Merck & Co. (Durham, NC)
- …grasping pushing and pullingAbility to travel WORKING RELATIONSHIPS: Reports to Quality Manager Interacts with employees within own department Frequent ... activities that support VMF, including periodic shop floor audits, direct in-line Quality support for all compliance and environmental monitoring matters, review… more
- BioAgilytix (Boston, MA)
- …to the patients who need them.We are seeking a highly organized and experienced Quality Assurance (QA) Manager with strong people management skills to lead our ... This role is pivotal in maintaining the highest standards of quality and compliance within our organization.Essential ResponsibilitiesDevelops, implements, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... of best practices and lessons learned. This role will also work with R&D Quality Assurance (R&D QA) and the respective operational functions to identify areas for… more
- Sun Pharma (Taro Pharma) (Billerica, MA)
- …manufacturer. Ensure all medical devices manufactured meet established specifications. Ensure compliance of establish Quality Management System (QMS) and in ... Device History Records related to medical device products.and continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory ... want to hear from you. Job Summary: As the Americas IT Security and Compliance Director, you play a pivotal role in ensuring the organization's adherence to… 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 ... assessments to prioritize investigations based on potential impact on product quality , patient safety, and regulatory compliance . Address recurring deviations… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at ... provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent...within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality … more
- Merck & Co. (Durham, NC)
- …last several years; currently Durham employs 1,000+ people.This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Merck & Co. (Durham, NC)
- …the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, ... LeadershipEnsure that Shift(s) objectives are achieved while reliably supplying a quality product at a competitive cost consistent with our Company, Regulatory… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...with other functional leads to improve operational performance and compliance will be a success factor for this role.This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role ... Overview The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...resolving complex scientific / technical problems Develops and evaluates quality processes and system standards to ensure compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product ... quality , integrity and compliance with regulatory guidelines and internal/global standards and procedures....complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the oversight, performance, and management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of ... International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …Marketing, Area Commercial Sales Team, Medical Affairs, Legal & Compliance and Human Resources. External relationships include responsibility for multiple ... Follows-up with internal and external stakeholders to review product value, quality of care and account satisfaction Physical Requirements 30-40% overnight travel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Organizations (CROs) and other vendors conducting the study to help monitor compliance with Quality Oversight measures. Responsible for staff training, ... research areas centered around rare diseases and immune disorders. Summary The Manager , Study Associates, under the guidance of the Associate Director, will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for best practices as per Legend Biotech policies and GXP requirements. Ensure compliance of operational activities with GXP, quality , training, EHS, security ... the treatment of multiple myeloma. Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role Overview… more
- Aequor (Seattle, WA)
- Job Description: Position: Technical Project Manager Location: Seattle WA Top Skills: 5&plus years' experience in bio tech/life sciences project management; cell ... CMC drug development. Familiarity with alliance management Job Description The Technical Project Manager (PM) will be a key member of the Cell Therapy Development… more
- Merck & Co. (Rahway, NJ)
- …support and mentoring to the CRA to ensure continuous development.Ensures CRA compliance to corporate policies, procedures and quality standardsExtent of Travel: ... and International Conference on Harmonization Good Clinical Practice (ICH GCP.)As line manager , the role is critical to continuously develop key talents by providing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
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