7 Gpvp Jobs

As the Quality Compliance Senior Manager at Amgen, you will play a crucial role in the Clinical & Research Quality (CRQ) team within the R&D Quality Organization. Your responsibilities will include providing leadership to maintain excellence in R&D Quality Processes, mentoring Amgen staff in India, managing day-to-day activities, and ensuring compliance with regulations globally. You will also support the digital quality management system (DQMS) and provide end-to-end quality support for managing Quality Incidents/Quality Events. Your key responsibilities will include: - Overseeing deviations, audits, and inspections across R&D Quality - Managing the Amgen India R&D Quality team - Facilitati...

Support the strategic development of an effective global risk-based audit strategy and program; collect, collate, and incorporate input into audit strategy and plan. Lead, plan, conduct, document, and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence. Provide technical guidance, leadership, mentoring, and training of other Auditors on audit-related activities. Prepare audit reports, according to NVS requirements and timelines. Ensure a...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details To lead a team of Drug Safety Physicians working on ICSRs Projects. Conduct initial assessment and Medical Review of ICSRs into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concomi...

The Quality Compliance Manager at Amgen plays a crucial role in the Continuous Improvement & Innovation team within the R&D Quality Organization. This global position involves supporting processes and initiatives focused on continuous improvement and change management. As the Quality Compliance Manager, you will contribute to Amgen's Quality Management System by developing and managing R&D controlled processes aimed at continuous enhancement through the application of standard methodologies such as Lean, DMAIC, and Six Sigma. In this role, you will collaborate with Business Process Owners globally to ensure compliance with regulations and other requirements while supporting the digital quali...

The Quality Compliance Senior Manager plays a crucial role in the Clinical & Research Quality (CRQ) team for the R&D Quality Organization at Amgen. The CRQ team ensures that research and development activities are conducted ethically and responsibly, meeting the highest standards of quality and compliance to keep patients safe and protect their welfare. This position involves providing leadership to maintain excellence in R&D Quality Processes, mentoring Amgen staff in India, managing day-to-day activities, and ensuring compliance with regulations globally. Additionally, the Quality Compliance Senior Manager will support the digital quality management system (DQMS) and provide end-to-end qua...

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...

Job Purpose: We are seeking a Team lead for our Biometrics function in India, who can manage a team of Biostatistics, Statistical Programming & Clinical Data Management. This role serves as the single point of contact for the Biometrics team in India, coordinating activities across functions and supporting alignment with global development goals. Proven expertise in Biometrics and expected, a solid understanding of all three functional areas is essential for cross-functional coordination and communication with U.S. leadership. Duties and responsibilities: Oversee the day-to-day activities of the Biostatistics, Statistical Programming & Clinical Data Management teams in India. Coordinate with...