Overview
ProPharma is currently supporting a development client within the Biological space as they require a Senior Consultant to support them in the QA/CMC area. At present the project will commence at the start of 2026; it will run until the end of 2028 and requires approx. 5-8 hours per week support. The project is to lead and create a Quality system for CMC Quality management and will be key in managing CMO partners and providing QA oversight.
Responsibilities
* Develop quality system for CMC Quality Management
* Quality management of contract manufacturing organizations (CMOs)
* QA oversight of CMOs which includes periodic audits of CMOs and testing laboratories
* Establish and manage quality agreements
* Oversee quality processes relevant to outsourced activities (Change control, Deviation/CAPA management, Product release, Annual product reviews)
* Conduct quality risk assessments of CMOs
* Review and approve all quality records generated by CMOs
* Leadership as QA Head
* Train internal staff on CMO quality oversight practices
Qualifications
* Must be educated to a BSc or higher within a Life-Sciences discipline or a related field with suitable industry experience
* Proven experience working at a senior level within Quality Assurance is a must
* Demonstrated experience building a Quality Management system would be preferred or at least management at a senior level
* CMC experience would be preferred ideally within a QA CMC role
* QA CMO management experience is a must
* Strong skills linked to aseptic/sterile products
* Fluency in English
* Can perform the project as described within the job spec
* Overall guidance and support from a QA CMC perspective as a SME
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