- 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
- 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
- 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
- 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
- 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
- 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. (Durham, NC)
- …procedures to resolve process/equipment issues, minimize downtime, and ensure product quality .- This role actively supports, participates, and embraces an inclusive ... team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required. Primary activities for this position… more
- Merck & Co. (Rahway, NJ)
- … compliance with all relevant regulations and guidelines.Calibrate, conduct quality control, and maintain lab equipment, including cell culture analytical ... highly motivated candidate to join our team as a Pilot-Scale Operations Lab Manager . This role involves managing, organizing, and providing support to the laboratory… 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
- 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
- Aequor (Thousand Oaks, CA)
- …mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global registration ... and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Title: Regulatory Project Coordinator… more
- Merck & Co. (Durham, NC)
- …manage project assignments.Ensure individually assigned aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management ... Job DescriptionOur Quality Assurance group ensures all materials inside our...project to construct the facility, process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of… more
- Aequor (Davie, FL)
- …environment. Maintenance and Projects Experience with strong focus on compliance , engineering and project management, preferably within Pharmaceutical or regulated ... and external personnel interfaces.Perform and support Process and Product Quality investigations including implementation of corrective actions (CAPAs).Ensure full … 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
- 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
- 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
