Quality and Compliance Lead


9th December 2020

Job Summary

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 (internal and external) through clinical stage and representing the Quality function in interactions with commercial partners, internal development teams and Midatech Management. 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 Responsbilities

  1. Review and continually develop QMS, SOPs and processes
  2. 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
  3. Review and approval of Quality documentation, agreements and reports
  4. Provide Quality oversight of CMC regulatory documents, including IMPDs and INDs
  5. Develop and oversee Quality Plans for clinical-phase manufacturing
  6. Perform Quality audits of external vendors
  7. Provide representation for Midatech Pharma Quality function with commercial partners
  8. Input to GCP activities as required

Job Factors

Minimum education level Degree in Pharmaceutical Sciences, or other related subject
Industrial experience Circa 6-10 years in 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.
Supervisory responsibility There are no requirements for the position to supervise other scientists at this time.
Personal attributes Strong work ethic. High attention to detail. Systematic approach to working. Phase-appropriate, risk-based decision maker Excellent documentation skills. Ability to work in and influence cross-functional teams.

Job Title

Quality and Compliance Lead

Salary

Commensurate with experience

Location

Cardiff, Wales or Home Based with significant presence in Cardiff site; occasional travel, as required

How to Apply

To apply for any vacancies listed please submit your CV and a cover letter to: careers@midatechpharma.com