- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical Affairs team, ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, Audit and Compliance , QMS QA, Development QA, and PVQA) to address ... audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA ... The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi… more
- Aequor (South San Francisco, CA)
- …power personalization, AI/ML classification, and dashboard reporting. Regulatory Support & Audit Readiness Ensure metadata compliance with regulatory standards ... reuse, search and discovery, lifecycle management, performance tracking, and audit readiness. You will work cross-functionally with content strategists, regulatory… more
- Eisai, Inc (Nutley, NJ)
- …analysis and negotiate fees/services with insurance brokerOther: Manage the annual treasury audit and ensure JSOX compliance for all processes; ensure standard ... coverage) for a marketed product across all relevant insurance lines; Lead audit calculations for premium adjustments; Manage the end-to-end process of claim… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Participant Reports. Audit data against supporting documentsReview all receipts for compliance and accuracy and that is has been properly documented in the ... have primary responsibility within Corporate Programs & Events for ensuring DSI's compliance with all CIA related policies, state and federal regulations regarding… more
- Formation Bio (New York, NY)
- …will play a key role in maintaining accurate financial records, preparing audit -ready schedules, and driving process improvements that enhance scalability and ... compliance .This is a full-time role that blends the reliability...and equity administration with the expertise needed in accounting, audit readiness, and treasury. The Senior Accountant will help… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure comprehensive auditing of Business Partners as required to assure compliance with PV agreements.Participate in audit and inspection readiness ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Eisai, Inc (Nutley, NJ)
- …and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality ... is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of continuous improvement in ... tool(s).Perform monitoring and tracking of the signal workflow to ensure compliance with procedural documents.When required, assist the product safety teams in… more
- Insmed Incorporated (San Diego, CA)
- …Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical ... regulatory agency inspections and vendor audits.Ability to ensure that a strategic audit plan is developed, designed and implemented, and that the activities are… more
- Merck & Co. (Durham, NC)
- …a focus on safety, current Good Manufacturing Practices (cGMP) compliance and efficiency.Define requirements and specifications for equipment.Manage the ... should be able to examine an issue from diverse perspectives (safety, compliance , automation, equipment, process, and people) in order to best understand and… more
- Merck & Co. (Rahway, NJ)
- …of CQO as appropriate. The CQOM will facilitate and oversee the responses to audit and inspection observations as appropriate.- In addition, the CQOM will work with ... result in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous Improvement (QCI)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, ... reports).Review and approve periodic review documentation for qualified equipment/systems ( audit trails, user groups, system administration)Provide expertise and solutions… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Shift Schedule: ... a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulationsWear the appropriate PPE when working in manufacturing and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities ... a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.Wear the appropriate PPE when working in manufacturing and… 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 opportunity to ... Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams… more
- Repligen (Waltham, MA)
- …Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including ... operational excellence initiatives in Quality Assurance.Maintain internal and external audit schedules; serve as host for site auditsMaintain risk-based strategy… more
- Merck & Co. (Rahway, NJ)
- …switches, dry-run modes, and time-limited actions. Ensure observability with audit logs, dashboards, and feedback loops. Collaborate across cybersecurity domains ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work with outsourcing procurement management ... developing and overseeing the implementation of CAPA in relation to sponsor's audit or regulatory inspections and ensure lessons learned are developed and… more
- Novo Nordisk Inc. (WA)
- …other Market Access & Public Affairs teams, Finance, Medical, Legal, Compliance , Communications and other key stakeholders locally and globally. External ... policies and procedures; Evaluate appropriate use of resources; Review and audit expense reports Physical Requirements 10-20% overnight travel required. Development… more
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