- Merck & Co. (Rahway, NJ)
- …compliance and operational excellence in the laboratories. Maintains a state of inspection readiness . Performs proactive resourcing planning and risk assessment ... Communication, Decision Making, Dosage Forms, GMP Compliance, Immunochemistry, Innovation, Inspection Readiness , Learning New Concepts, Manufacturing, Microbiological… more
- Insmed Incorporated (NJ)
- …training to ensure consistent and compliant execution across Patient Services.Lead audit readiness and inspection management for internal QA, client, and ... the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and process improvement… more
- Insmed Incorporated (NJ)
- …closely with our QA organization to implement and manage a process for Inspection Readiness .Contributes to the development and review of regional/global policies ... 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study oversight and execution.Ensure their direct reports are maintaining a state of inspection readiness across all activities on their study and making sure ... measures in place to course correct where needed. The Director will be accountable to support SDL and employee...reports are properly trained, following process and SOPs. The Director will ensure the Senior Director , Clinical… more
- Merck & Co. (Rahway, NJ)
- …excellence in the laboratories, and for maintaining a state of inspection readiness at all times. The Director should be well engaged with regulatory ... Communication, Cross-Functional Teamwork, Decision Making, Dosage Forms, GMP Compliance, Inspection Readiness , Medical Device Management, Medical Device… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sites. In addition, this role will support Compliance initiatives, such as inspection readiness , metrics implementation and review, overall regulatory compliance ... landscape to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Review Prospective & Retrospective Quality Review of cases Regulatory Intel & Inspection Readiness Maintains up to date knowledge of the regulations and ... you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers...reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor… more
- Merck & Co. (Rahway, NJ)
- …GMP Auditing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Inspection Readiness , Quality Auditing, Quality Management, Quality Management ... Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director , will report to the Animal Health Global Quality Compliance and Technical Lead.--… more
- Merck & Co. (Rahway, NJ)
- …and execution of design verification strategies, and design transfers for testing readiness , which includes incoming and release tests for components and combination ... employees at all levels to effectively engage and coordinate the implementation/ readiness and execution of design verification tests and methodologies in support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applicable regulatory requirements, and other relevant guidelines.Is accountable for inspection readiness of DM programming documentation filed/archived ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …into an annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs.Ensure proactive representation of ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...during inspections and external audits. Ensure ongoing submission and inspection readiness for the respective Medical Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …required to assure compliance with PV agreements. Participate in audit and inspection readiness activities. Provide input for remediating PV system deficiencies ... cited in audit/inspections. Implement effective corrective and preventative action PV Agreements and Contracts: Manages PVAs/SDEAs and maintains oversight of PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the preparation and execution of internal and ... external audits and regulatory inspections Ensure documentation and processes are audit-ready and aligned with global pharmacovigilance standards Physical Requirements 0-10% travel required. Development Of People Supervisory. Verbiage below applies only to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and quality delivery and regulatory compliance of outsourced activities.- Ensures inspection readiness of all data management activities conducted internally ... areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE)...a global and regional level as required.Support audit and inspection readiness activities as a subject matter… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and ensure appropriate documentation Perform case follow-up activities Participate in inspection readiness and support audits/ inspection as required ... of assigned projects in Patient Safety. Relationship Reports directly to the Director , Patient Safety Case Management. This role involves the case handling and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …templates meet both Global and local regulatory requirements Supports audit and inspection readiness Develops and maintains company (safety) SOPs Business ... with SDEA requirements. Relationships This position reports to the Associate Director , Safety Contracts & Supplier Management. This position works closely with… more
- Sandoz Group AG (Princeton, NJ)
- …Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Inspection Readiness , Leadership, Logical Thinking, Major Incident ... personally. Join us as a Founder of our 'new' Sandoz! As the Associate Director , Market Product Quality you will be responsible for the execution of processes… more
- Northrop Grumman (CA)
- …Board (MRB), Program Management Reviews (PMR), Design/Peer Reviews, Manufacturing/Test Readiness Reviews and Corrective Action Boards (CAB). Collaborate with ... degree). Experience with quality engineering principles, manufacturing operations, product inspection , test & evaluation, reliability, root cause analysis, defect… more
- CytomX Therapeutics, Inc. (South San Francisco, CA)
- …collect documents from sites, manage and update expected document lists) and ensure inspection readiness of the eTMF through ongoing TMF completeness checks. ... CA Candidate Location: Hybrid Travel Required: 5% Reports To: Sr. Director , Clinical Operations Department: Clinical Operations Position Type: Temporary (6-12… more
