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The primary focus of this job is to lead and guide the late stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services at...
Owning all quality related responsibilities for the CQV Lifecycle Program for new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs;...
The core responsibility of the role is to provide Global Quality Assurance leadership and oversight of global pharmacovigilance systems. Globally responsible for establishing a...
This role will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and network projects...
In this role, you will develop and embed a consistent Quality Culture across all affiliates, ensuring that robust quality systems and processes are in place to support Sobi’s...
Ensure quality checking or approval of documents needed to manufacture and release batches such as the master batch records, related documents (instructions, forms, development...
Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan...
Provide independent and high-quality scientific advice and expertise to support the Executive Director in developing the overall vision and strategy necessary for the agency to...
Microbiology testing when required, ensuring that all support testing is carried out within the required timelines and in compliance with GMP and GLP guidelines. Working with...
You actively contribute to the strategy to become a center of excellence in the development of biologics, small molecules, and medical devices. Design and lead a global...
Responsible for managing daily activities related to quality, including campaign preparation, change control, deviation & CAPA management, and process monitoring. Ensures...
This position supports process development, regulatory interactions/submissions, and clinical and commercial manufacturing. The role also oversees early access and commercial label...