- Merck & Co. (Rahway, NJ)
- …in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous Improvement ... preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and ... audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA… more
- Merck & Co. (Durham, NC)
- …Reviews, Operations Support, Process Optimization, Production Scheduling, Production Support, Regulatory Compliance {+ 4 more}-Preferred Skills:Job Posting End ... Conforms to established safety procedures in accordance with OSHA and other regulatory agencies- Identifies and addresses compliance , environmental, safety, and… 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)
- …within a biopharmaceutical silicone and plastics injection molding facility, ensuring compliance with cGMP, EHS, and regulatory requirements. This role ... Leadership (Primary Focus):Manage day-to-day production activities to meet EHS, Quality , Productivity, and RPS Lean objectives.Ensure compliance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of… 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 ... removing roadblocks and engaging cross-functional experts to maintain progress.Support regulatory audits and inspections by collaborating with stakeholders and … more
- Repligen (Waltham, MA)
- …Change Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate ... team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global...root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is… more
- Merck & Co. (Durham, NC)
- …and implementation of preventative and predictive maintenance programs to assure compliance with quality , regulatory , and reliability requirements ... site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage… 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. (Rahway, NJ)
- …Analysis, Ethical Standards, ICH GCP Guidelines, Medical Writing, Motivation Management, Regulatory Compliance , Regulatory Documents, Science, Scientific ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… 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)
- …operations and/or large facility builds or renovations.A thorough understanding of regulatory / compliance expectations across all phases of product development ... with key stakeholders.Training skills: Ability to train employees in technical, compliance , safety, and environmental procedures; ability to write SOPs and technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Aequor (Thousand Oaks, CA)
- …trials. You will collaborate across functions, troubleshoot distribution issues, and ensure compliance with regulatory and quality standards. Key ... 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 ... on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …but not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality .Work closely with Sr. Manager , Strategic Initiatives to support various ... in a heavily regulated pharmaceutical environment with adherence to strict regulatory guidelines and internal compliance policies.In depth understanding of… more
- Tris Pharma (Houston, TX)
- … compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to sales inquires, disseminate scientific information ... Under direct supervision and training from the Regional Sales Manager (RSM) and/or other appropriate senior Sales colleagues you...and report Adverse Events (AEs) and Product Quality Complaints (PQCs) Conducts office visits to establish, develop… more
- Aequor (Vacaville, CA)
- Manager is trying to work within the allocated budget. The max supplier bill rate will be /hr - please do not exceed this (any candidates that exceed the rate will ... (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and… more
- Houston Methodist (Houston, TX)
- …with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager ** QUALITY /SAFETY ESSENTIAL FUNCTIONS** + ... and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for … more
