- Creative Financial Staffing (Columbus, OH)
- …Financial Expertise: In-depth knowledge of accounting principles and regulatory compliance . Requirements For The Accounting Manager : Strong proficiency in ... Ignite Your Career as an Accounting Manager in Columbus, Ohio! Are you a seasoned...quality of life. The Role: As our Accounting Manager , you'll be the driving force behind our financial… more
- Aequor (Thousand Oaks, CA)
- …registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs ... regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications. o Ensure compliance with submissions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with legal and compliance as required. Proactively collaborate with other GxP quality representatives and act as QA point person for US and EU Medical Affairs ... learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations… more
- Aequor (Athens, GA)
- …within the regulatory department and stakeholder groups relative to regulatory compliance of BIAH products and processes. With minimum guidance ... Shift Anywhere between 8 am to 5 pm, Monday-Friday as scheduled and aligned with manager . Hours 20 hours per week Number of positions 1 Any possibility of the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Readiness: Oversee and or participate in internal audit programs and lead IS quality audits to ensure regulatory compliance and successful outcomes. ... Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead...in the operational execution of Quality and Compliance GxP processes including audits, regulatory intelligence,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with ... amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service… more
- Insmed Incorporated (San Diego, CA)
- …a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... Manager , you will be responsible for the daily oversight...support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing. Assist in creating a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements ... procedures to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management System and GMP Compliance Programs to assure product quality , integrity and compliance with regulatory guidelines and internal/global ... the timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible… more
- Merck & Co. (Millsboro, DE)
- …other departments.Review and revise processes and procedures against corporate and regulatory requirements to ensure compliance .Review production records for ... including poultry, equine, swine, bovine and companion animal.- The operations manager is responsible for managing Packaging activities for biological production as… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Durham, NC)
- …packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal ... Job DescriptionOur Quality Assurance group ensures every single material inside...uses this knowledge in own work Understands and applies regulatory / compliance requirements relative to their role… more
- Merck & Co. (Durham, NC)
- …for activities that support Good Manufacturing Practice and regulatory compliance during product manufacturing:Direct in-line Quality support for all cGMP ... grasping pushing, and pulling.Ability to travel. WORKING RELATIONSHIPS: Reports to Quality Manager Interacts with employees within own department Frequent… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …problem-solving and decision-making skills using data analysis.Familiarity with regulatory requirements, safety standards, and compliance .Visionary mindset ... Position Summary The General Manager and VP of Manufacturing will be a...allocation for maximum efficiency and growth.Establish and maintain strict quality control measures, meeting industry and customer standards.Attract, retain,… 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. ... trouble shooting and resolving complex scientific / technical problemsDevelops and evaluates quality processes and system standards to ensure compliance with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work...third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern… more
- Eisai, Inc (NJ)
- …and management. Collaborates with study teams, legal, finance, clinical planning, compliance , clinical quality , data protection, IT security and other ... functions, as required. Ensures compliance of work product to SOPs, guidelines, work instructions...product to SOPs, guidelines, work instructions and GCP and quality standards. Manages, under supervision, the development, implementation, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and 10 Essentials in all activities and interactions with othersSupport other quality compliance and implementation projects, as assignedOther Duties as ... a key player in the Deviation Response Team team and a champion for quality priority principles and compliance within the organization.This role is a full-time… more
