- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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)
- …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)
- …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
- GRAIL (Durham, NC)
- …are in conformance with international and local requirements. + Develop, manage and execute inspection readiness programs across the GRAIL QMS to ensure site ... a key member of the Quality Leadership Team, the Director of Quality Audits will be responsible with overall...readiness at all times, including inspection logistic… more
- WuXi AppTec (Middletown, DE)
- …requirements and client expectations, while driving continuous improvement and inspection readiness . **Responsibilities** QC Program Leadership - Provide ... operations for WuXi STA's new DE site. The QC Director will lead all Quality Control functions for WuXi...USP, EP, JP, and other applicable guidelines. - Maintain inspection readiness at all times; prepare for… more
- Endo International (Horsham, PA)
- …and related international regulations. + Quality systems, batch documentation, and inspection readiness + Technology transfer, including CMC documentation and ... and compliance objectives, ensuring the facilities are in a constant state of inspection readiness and compliant with regulatory agency requirements. + Ensures… 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
- BeOne Medicines (Emeryville, CA)
- …a compliant, consistent, and audit-ready manner. Additionally, the role supports inspection readiness , regulatory intelligence, audits, compliance analytics, and ... programs are aligned with global health authority expectations. + Contribute to inspection readiness planning and execution, including pre- inspection … more
