Addlestone
• QA CMO Manager, 12-month Contract (MAT Cover), • Addlestone, Surrey – 1x a quarter on site, • £500 per day – Inside IR35 Cpl Life Sciences is partnering with a growing pharmaceutical company that is looking for a QA CMO Manager on a 12-month basis. The purpose of the assignment is to maintain CMO oversight/management and associated activities during the maternity leave of the permanent CMO manager. CMO QA Oversight: • Oversees the cGMP activities and processes for commercial drug substances, intermediates, and in-process and finished drug products manufactured by CMOs, supported by the line management., • Provides QA oversight for technology transfers of commercial products to and between CMOs., • Provide QA support for regulatory agency inspections at CMOs as necessary., • Participate in CMO Business Review Meetings., • Facilitates the resolution of all deviations, non-conformances and other batch related quality issues with the CMO to ensure product compliance., • Employs a Risk Management approach to evaluate Quality issues to ensure that drug substances, intermediates, and in-process and finished drug products manufactured by CMOs conform to all regulatory and business product specifications. Interactions: Internal • Product and Project management, • CMC RA, • Quality assurance, • Legal, • Supply chain, • Technology and Manufacturing External, • Contract Manufacturing Organizations Prior Experience: • Influencing: ability to communicate with stakeholders, clearly provide QA assessments, reasoning and align to consistently ensure compliance and patient safety, • Decision making, • Project management, • Previous experience in pharmaceutical Quality Assurance, CMO oversight or in-plant GMP pharmaceutical manufacturing, • Experience working with Biologics For more information, please reach out to me at
