- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event,… more
- Merck & Co. (Upper Gwynedd, PA)
- …least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.Knowledge and understanding of ... of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for...in outcomes that demonstrate the Company's commitment to regulatory compliance .Ensures that a cross-functional team (eg Quality … more
- Merck & Co. (North Wales, PA)
- …biopharmaceutical company. We are seeking an Associate Director, Clinical Systems Implementation to manage activities related to the successful implementation ... application related decisions that may or may not have a global impact.-Ensure compliance to Company, local laws and agency regulations and related guidance around… more
- BioAgilytix (Durham, NC)
- The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information ... to post-implementation support, with a strong focus on regulatory compliance and lab efficiency.Key ResponsibilitiesProject Leadership: Lead the onsite planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global ... DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems … more
- Aequor (Thousand Oaks, CA)
- …to ensure projects deliverables are completed on time and adhere to high quality standards.Scope includes a wide range of devices, such as; needle protection ... systems , fluid transfer devices, pen injectors, automatic pen injectors....a daily basis, identifying resource needs; and escalating functional, quality , timeline issues appropriately. Responsible for tracking key project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring ... ensure business objectives are met Manages and monitors organizational compliance with all established supplier agreements Provides strategic procurement… more
- Aequor (West Greenwich, RI)
- …and other applicable regulations Provide support for Global Process Owners executing key quality systems processes Ensures the Quality unit provides review, ... is the working environment for this role? Role supports quality management systems , office based, EW will...process performance and areas of improvement Alerts senior management of significant quality , compliance , supply and safety… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is accountable for clinical phase 1… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationship with key stakeholders and senior management within Finance, Legal, IT, Quality , Compliance and Product Safety. Leads an Operations team comprising ... based on KPIs, while delivering on the objectives of process agility, quality output, strong collaboration, and high productivity from team members. Ensures the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …opportunities, review issues log, develop risk mitigations strategies and ensure all systems are operating well as designed. Ensures compliance with internal ... of all Financial Disbursements technology applications and other linked systems . Translates business / functional goals into appropriate Financial Disbursements… more
- Novo Nordisk Inc. (Little Rock, AR)
- …makers, including but not limited to: Payers/Regional PBMs, Health Systems with aligned Payers, Municipalities, Coalitions, Specialty Pharmacy, Federal Agencies ... Marketing, Area Commercial Sales Team, Medical Affairs, Legal & Compliance and Human Resources. External relationships include responsibility for multiple… more
- County of San Diego (San Diego, CA)
- …Maps, Final and Parcel Maps, Lot Line Adjustments, Mergers, Certificates of Compliance ). * Reviews Records of Survey, Corner Records, Certificates of Correction and ... supervision. Qualifying experience will include CAO Staff Officer or Project Manager experience that involves leading projects. This position requires current State… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor performance, assessing spend, maximize value from vendors, ensure service quality . Reduce costs without compromising quality . Monitor projects and ... potential risks, including any third-party disruptions.- Evaluate current vendor processes and systems for continue to enhance programs. - Legal and Compliance … more
- Eisai, Inc (Nutley, NJ)
- …organizational, and commercial requirements that govern the organization's technology systems and information assets.Purpose of role:Oversee IT compliance ... Manager (CISM) certification is essential. Additional Certified Information Systems Auditor certification is advantageous.ISO 27001:2013 Lead Implementer /… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist, Quality Systems and Compliance (P3) Our company is expanding its global recombinant vaccine production network by investing ... comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.- - The Quality Senior Specialist provides expertise in the coordination of… more
- Aequor (Louisville, KY)
- …IS organization and external vendors. The position will report into the Sr. Manager Supply Chain Compliance . Accountabilities Embed the principles of Good ... of a Life Sciences degree, 4&plus years' experience in GMP / GDP compliance Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and ... requested.Identify and implement process improvements related to safety, environmental, quality , compliance , productivity, yield, and cost.Implement process… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to manufacturing equipment, facilities, or processes in compliance with existing Quality Agreements.Keeps department manager up to date. Seeks guidance on ... and justified.Advise end-users on documentation mechanisms to ensure adequate compliance to GMP.Leads or contributes to Quality ...and three (3) to five (5) years in the Pharmaceutical Industry, preferably in a Quality Systems … more
- Merck & Co. (Millsboro, DE)
- …at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the ... (IACUC), and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other… more
