cGxPServe

Job Description: We are seeking a Quality Engineer with experience in the medical device industry to support quality assurance regulatory compliance and continuous improvement initiatives. The ideal candidate will have a strong background in FDA regulations ISO 13485 risk management ( More...

Responsibilities: The Associate Regulatory Affairs Manager will support the development review and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulatory projects ensuring compliance with FDA ISO 13485 and other global reg More...

Job Description: We are seeking a highly experienced Laboratory Information Management System (LIMS) Subject Matter Expert (SME) with 10 years of proven expertise in the implementation optimization and support of LIMS solutions within clinical and research laboratory environments. Th More...

Responsibilities: Lead and manage clinical data management activities for oncology clinical trials ensuring adherence to project timelines budgets and quality standards. Provide strategic oversight and direction to CRO clinical data management teams for assigned studies. Develop and More...

Job Description: In this role youll ensure manufacturing processes meet quality and regulatory standards while driving improvements across production and compliance. This is a hands-on role with strong cross-functional collaboration and an emphasis on risk management validation and p More...

Job Description: Key Focus: FDA experience is highly valued especially if youve led process revamps or redesigned processes reviewed and validated by the FDA. Join a team driving medical device quality and process development bridging compliance requirements and real-world business n More...

Job Description: Were looking for purpose-driven passionate individuals to join our team. From clinical to commercial to supporting functions Use statistical programming software to develop datasets and tables figures and listings that comply with regulatory standards and support the More...

Job Description: The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with conn More...

Job Description: The Regulatory Affairs Manager is the primary point of contact and responsible for facilitating regulatory oversight and management in all phases of drug development. Managing multidisciplinary teams and client interactions to ensure key regulatory milestones and time More...

Responsibilities: Lead the data management activities from study start-up through the entire data cleaning process until database lock to support the clinical studies. Oversee all project related data management activities and manage project resources and timelines to ensure delivera More...

Job Description: We are seeking a highly motivated full-stack web application developer (contract) with exceptional programming skills to join Vaccines R&D in Pearl River NY contributing to the research efforts for various vaccine research programs. This individual will join as a mem More...

Job Description: The Quality Process Engineer will be responsible for developing and maintaining process control systems to ensure consistent product quality with a focus on supporting the insourcing of materials and components. This role leads cross-functional efforts to qualify int More...

Roles & Responsibilities: 10 years of MES experience in Manufacturing and Medical Device Domain (MDD). 5 years of working experience in managing Critical Manufacturing MES implementations and Rollouts master data modelling and enrichment. Certified Critical Manufacturing Professional More...

Job Description: Develops establishes and maintains quality engineering methodologies systems and practices which meet BSC customer and regulatory requirements. Serves as a Quality representative to improve awareness visibility communication on quality initiatives to support departme More...

Responsibilities: Lead PFMEA activities in coordination with product development quality and manufacturing engineering teams. Participate in DFM and DFA activities to define manufacturing processes for new products and product enhancement programs. Develop manufacturing assembly and More...

Responsibilities: Serve as the principal programming lead across multiple studies or a clinical program ensuring timely accurate and regulatory-compliant deliverables. Lead or contribute to the development validation and documentation of SDTM ADaM and TFLs in support of clinical stud More...

Responsibilities: The Senior SAS Programmer / Statistical SAS Programmer is responsible for providing programming support for clinical trials and contributing to the development of departmental standards. This includes developing and validating SAS programs for statistical tables dat More...

Responsibilities: Author and compile CMC sections of regulatory applications including INDs IMPDs CTAs amendments and annual reports. Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries stability reports and comparability protocols More...

Job Description: The Senior Engineer position within the Science and Technology (S&T) organization is responsible for the development improvement and verification of electro-mechanical medical devices. This technical expert will with little supervision primarily apply engineering know More...

Job Description: Conducts internal audits of the Quality Management System at the corporate product group and subsidiary levels. The support of these functions also includes Management of third party registered body contracts and planning planning and execution of external customer a More...