substance and intermediates. Work collaboratively with Analytical Development, Regulatory, Quality Assurance and with project... content. Draft and review regulatory documentation. Work closely with Quality Assurance in evaluating and approving...
, and control systems to reduce costs, streamline procedures, and ensure regulatory compliance of the global supply chain. Works... across functions (CMC, Clinical Operations, Quality Assurance, Regulatory, Sales, and Finance); Works with finance/accounting...
such as Manufacturing Engineering, Technical, Process Development, Supply Chain, Quality Assurance and Quality Control... to Management regarding serious compliance or quality issues. Routinely report on quality . and compliance issues Leads multiple...
development lifecycle process Ensure compliance with regulatory standards, including GMP, ICH, EMA, and FDA guidelines. Support... the preparation of global regulatory submissions, scientific reports, and patents. Develop phase-appropriate quality...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare... Services / Manufacturing Science (TS/MS) Sr Director is responsible for providing leadership to the TS/MS function for the...
and/or quality operations or quality systems working in a GMP environment Management of Quality Assurance Staff Display... Quality Unit (Quality Assurance, Quality Operations and Quality Control), a proactive development of the Quality System...
., contract research organization teams and vendors). Supports Quality Assurance activities during pre-approval GCP and GMP FDA...-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global...
compliance with regulatory standards and maintaining the highest quality in our products. This position is based in..., including Quality Assurance, Manufacturing, Engineering, Quality Control and R&D, to ensure validation activities are integrated...
compliance with regulatory standards and maintaining the highest quality in our products. This position is based in..., including Quality Assurance, Manufacturing, Engineering, Quality Control and R&D, to ensure validation activities are integrated...
and Quality compliance, and business needs. Work closely with Development and Global Regulatory teams to author/review.... As a result, our Global Quality Analytical Sciences & QC Operations organization who is responsible for delivering the...
regulatory submissions, and be familiar with compliance of GMP operations in support of advanced therapy operations. Essential..., Analytical Sciences & Technology, Manufacturing Operations, Quality Control, Quality Assurance, Regulatory CMC, Supply Chain...
Associate Director Quality Strategy and Operations Today, Lonza is a global leader in life sciences operating... a forward-looking organizational development of the Quality Unit (Quality Assurance, Quality Operations and Quality Control), a proactive development...
are determined to make life better for people around the world. Associate Director Quality Assurance (QA) Parenteral is responsible... for the staffing, training, and leadership of the quality assurance group supporting the project/expansion delivery, process...
are determined to make life better for people around the world. Associate Director - Quality Assurance (QA) Packaging... is responsible for the staffing, training, and leadership of the quality assurance group supporting the project/expansion delivery...
high quality CMC sections for global regulatory submissions (IND/CTA, and BLA/MAA), applying agreed CMC global regulatory... with project timelines. Work in partnership with Quality Assurance and CMC teams to ensure adherence to Good Manufacturing...
is a technical expert in the principles and application of Quality Assurance and compliance, specifically in process validation... and reports to the Senior Director, GMP Operations Quality. The successful candidate will ensure timely delivery to support the...
Director will collaborate with teams, including R&D, Quality, Manufacturing, and Regulatory Affairs, to the... across several locations. Create and deploy global technical standards for cell therapy, focusing on process validation, sterility assurance...
operational excellence Ability to apply phase appropriate GMP compliance principles to quality decisions Ability to lead... approach, ensure phase appropriate GMP operations are in compliance, while maintaining an efficient workflow to facilitate...
and Quality Assurance comments. Provides staff supervisory functions in areas of hiring, titling, discipline and retention.... Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in...
into Eurofins LIMS for reporting to clients. Responsible for addressing data review comments and Quality Assurance comments.... Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in...