- Merck & Co. (Rahway, NJ)
- …well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is ... and result in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.- Position Description - This is a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems and procedures.Ensure trending… more
- Merck & Co. (Durham, NC)
- …during tours to provide area/process overview information to visitors/auditors upon request-- Quality & Safety Compliance - Foster strong safety culture on the ... reporting safety issues and completing corrective/preventative actions-Drive culture of compliance through actions, consistent quality -driven decision making,… more
- Repligen (Clifton Park, NY)
- …Leadership (Primary Focus):Manage day-to-day production activities to meet EHS, Quality , Productivity, and RPS Lean objectives.Ensure compliance with ... OverviewThe Production Manager will oversee daily manufacturing operations within a...a biopharmaceutical silicone and plastics injection molding facility, ensuring compliance with cGMP, EHS, and regulatory requirements. This role… more
- Merck & Co. (Boston, MA)
- …more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to ... regulatory audits and inspections by collaborating with stakeholders and Quality units to provide documentation and respond to inquiries.Actively drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global supplier base. This is an ... is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality .Responsibilities Supplier Performance Monitoring and ReportingCollect,… more
- Merck & Co. (Durham, NC)
- …and implementation of preventative and predictive maintenance programs to assure compliance with quality , regulatory, and reliability requirements and ... site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage… more
- Merck & Co. (Irving, TX)
- …direct management direction, coordinates production associates to meet production schedules in compliance with the Quality System, EHS and company policies while ... of equipment and material resources to optimize performance.Assists the manufacturing manager to ensure production schedules are met.Verifies compliance of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, ... supervisory activities for designated team members.Support Investigations team by providing quality and compliance input for continuous improvement; and… more
- Merck & Co. (Durham, NC)
- …and implementation of new systems which enhances the operation and/or engineering processes. Quality & Safety Compliance :The successful candidate should be able ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Merck & Co. (Durham, NC)
- …The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the ... an inclusive team culture including significant interaction with operations, quality , automation, technology, and other groups as required.Key Duties:Ability to… more
- Merck & Co. (Rahway, NJ)
- …with key stakeholders.Training skills: Ability to train employees in technical, compliance , safety, and environmental procedures; ability to write SOPs and technical ... single-use environment, and bioprocessing equipmentStrong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for… more
- Aequor (Thousand Oaks, CA)
- …You will collaborate across functions, troubleshoot distribution issues, and ensure compliance with regulatory and quality standards. Key Responsibilities and ... systems go down and manual processes required. Experience with Quality Management Tracking Systems (QMTS) is preferred but not...Supply Chain is preferred but not required, and the manager is open to both seasoned professionals and motivated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she ... failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing...of this analysis can be conveyed to the Maintenance Manager in a structured way so that he can… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Rahway, NJ)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Novo Nordisk Inc. (Durham, NC)
- …response Read & follow SOPs, job instructions & other documents to ensure compliance Identify, report & resolve quality issues Assist during equipment ... to embark on the opportunity to help improve the quality of life for millions of people around the...2:30am) includes 10% shift differential Relationships Reports to Shift Manager . Essential Functions Setup, operate, monitor & control equipment,… more
- Tris Pharma (Houston, TX)
- …our Houston territory. Under direct supervision and training from the Regional Sales Manager (RSM) and/or other appropriate senior Sales colleagues you will be part ... Adheres to all Standard Operating Procedures (SOPs), policies, processes and compliance guidelines and ensures knowledge of legal and regulatory requirements to… more
