Quality & Compliance Lead
Attractive salary & package
- Working on novel drug formulations and manufacturing processes, the position will involve the ongoing development of the QMS documentation relating to GMP activities, providing Quality oversight of all CMC activities.
- The position will develop and implement Quality plans and processes for relevant programs.
- The position will guide and support clinical manufacturing requirements, providing Quality and Compliance input across manufacturing process development, analytical development and tech transfer activities.
- Working closely with manufacturing and analytical partners to meet internal and customer requirements, the position holder will ensure a phase-appropriate approach that meets the requirements with regards to quality, cost and time.
- Review and continually develop QMS, SOPs and processes.
- Provide Quality and Compliance support to clinical stage CMC activities, including but not limited to, CMO vendor selection, development and technology transfer of manufacturing processes and analytical methods, drug product manufacturing activities, stability studies.
- Review and approval of Quality documentation, agreements and reports.
- Provide Quality oversight of CMC regulatory documents, including IMPDs and INDs.
- Develop and oversee Quality Plans for clinical-phase manufacturing.
- Perform Quality audits of external vendors.
- Provide representation for Pharma Quality function with commercial partners.
- Input to GCP activities as required.
- Degree in Pharmaceutical Sciences, or other related subject.
- Industry experience within a related Quality/pharmaceutical development environment.
- Experience in early development and of transitioning programs into a GMP environment to support manufacture for clinical trial supply.
- Knowledge of GCP would be an advantage.
- A great communicator.
If you're interested please apply online, for further information about the position call Bal on 0121 728 8455 to discuss.
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