Head of Quality
- Reference: JLS HOCQ
- Location: South Wales
- Salary: Dependent on experience
- Type: Temporary
- Start: ASAP
Just Life Sciences are seeking a driven and experienced Head of Quality and Compliance leader.
Qualifications, Skills and Experience
- Who will be involved with the ongoing development of the QMS documentation relating to GMP activities, providing Quality oversight of all CMC activities (internal and external) through clinical stage and representing the Quality function in interactions with commercial partners, and internal development teams.
The position will develop and implement Quality plans and processes for relevant programs, providing timely input to support agreed project milestones.
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.
- Specific Responsibilities
- 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
Represent the Quality function with commercial partners
Input to GCP activities as required
- If you are interested then please apply to firstname.lastname@example.org
Just Life Sciences
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