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Reporting to the Vice President, Global Head of Safety and Pharmacovigilance, the Director, Safety Scientist will be responsible for the oversight of medical safety functions for Immunomedics’ products, both those in clinical development and marketed products. The Safety Scientist will assist the Senior Medical Director and Medical Director in performing medical safety functions, including ongoing safety surveillance of Immunomedics’ products, activities related to the Safety Management Teams, and preparation of periodic and other aggregate reports of safety data. The Safety Scientist will represent Safety and Pharmacovigilance in Clinical Development project teams.
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The purpose of the Senior Manager role is to:
1) Develop category strategies for raw materials, supply chain/logistics and other assigned categories.
2) Plan and execute the sourcing process for all relevant activities.
3) Execute and adhere to Corporate Procurement strategy, policy, systems, and processes.
The Senior Manager, Raw Materials and Supply Chain Sourcing will work within multi-disciplinary team and assume responsibility for leading the development and execution of Raw Materials/Supply Chain sourcing strategies to leverage relationships with suppliers, global affiliates and CMO partners to gain competitive advantage. This includes negotiation, supplier relationship and performance management, and risk management. Strengthens and develops relationships with key partner organizations.
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We are seeking a Senior Statistical Programmer to provide statistical programming and analytic support clinical studies.
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This position requires a sound working knowledge of clinical data management processes and database systems within a multi-disciplinary team environment.
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We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The Oncology Sales Specialist, is a key position within the Immunomedics commercial team. The position will report to the Regional Business Director.
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Creates, reviews, and revises technical documentation of procedures and practices associated with the Validation department. Ensures appropriate maintenance of technical documents, provides various support, and coordinates activities for the Validation department.
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The Validation Engineer will be responsible for the completion of assigned validation projects encompassing equipment, instruments, computers, cleaning, and process areas for the entire validation lifecycle.
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As a key member of the Quality Assurance and Compliance Department, develop and maintain the Immunomedics Validation Programs. Manage projects according to Master Plan for computerized systems, cleaning, and environmental (air and water system) areas for entire validation lifecycle. Continually evaluate technological solutions for implementation. Ensure excellence of documentation and record retention.
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This position will be responsible for providing clinical supply plans, packaging configurations and distribution strategies.
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The Senior Director of Compliance will be responsible for the development, implementation, maintenance and continuous improvement of global Compliance programs to support Global GxP operations and supply within Immunomedics and ensure compliance with relevant regulations.
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We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The Oncology Sales Specialist, is a key position within the Immunomedics commercial team. The position will report to the Regional Business Director.
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We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The Oncology Sales Specialist, is a key position within the Immunomedics commercial team. The position will report to the Regional Business Director.
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Associate Director of Quality Systems provides oversight to Quality Systems such as change control process, document control / management, Risk Management and, Computer System Validation (CSV), and general QA Validation oversight. Quality System group will also manage Quality System updates and provide day to day management to these Quality Systems. QA System group will provide trending for Quality Systems. This position may also be cross trained to cover other QA functions as needed.
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The GMP Training Manager is responsible for ensuring that the training and qualifications systems are in place to assure that personnel are trained, qualified and competent to perform their assigned job functions in accordance with regulatory requirements and IMMU Policies and Procedures.
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Manage GMP Training Program, company-wide, and assure that company-wide GMP training is performed in compliance with Current Good Manufacturing Practices, company policies and procedures.
Oversee Administration of the ComplianceWire Learning Management System (LMS) including workflows for user access/ security roles, assignments/ curriculums / user groups, SOP revisions, data entry/ organization, custom fields
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Sr.Director of CQA provides Strategic vision and oversight for the Clinical Quality Assurance System including Clinical Standards development and maintenance, Clinical Audit Program, Good Clinical Practice Training and Clinical Inspection Readiness Program. The incumbent will oversee internal quality systems and processes within Clinical and R&D functions to ensure compliance with applicable regulations and requirements; in collaboration with Line Functions or other business process owners, ensure that applicable clinical development, research related processes and quality standards are designed and implemented in line with health authority requirements. Drives the implementation of robust GxP (GCP, CSPV, PV) Quality Management System and Processes for all regulated areas where clinical trial activities are allocated and or executed. Facilitate through proactive and strong leadership; business process excellence to facilitate process simplification and improvement initiatives within the organization. Ability to share/ implement vision and strategy within the responsible line functions as well as globally. Directs globally Clinical processes for improving efficiency by optimizing processes necessary for continuous improvement at the regional and global levels. Together with Management teams, plans, supports conduct and reports Clinical Research and Pharmacovigilance quality assessments at regional level and supports GCP/CSPV/PV inspections across the organization and affiliates.
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The Manager, CMO - Quality Assurance is responsible for managing activities within Quality Assurance for all CMO (Contract Manufacturing Operations). This position also contributes to the completion of routine technical tasks and any additional quality task identified.
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Manages the Clinical Quality Assurance System providing oversight to Clinical Standards development and maintenance, Clinical Audit Program, Good Clinical Practice Training and Clinical Inspection Readiness Program. The CQA group will also manage Quality System updates and provide day to day compliance assistance to Clinical Study Teams.
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Responsible for Quality oversight for the warehouse and raw material release. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations in the warehouse. Assure that raw material released complies with all applicable regulations and guidelines.
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Provide Quality assistance and oversight during manufacturing of in-process, upstream and downstream, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.