Jason Johal at CK Science is currently recruiting for a Quality Manager to join a new technology and innovation centre based in central London.
The Quality Manager will take day to day responsibility for ensuring company systems and procedures, including those covering laboratory, clinical and regulatory activities, are fit for purpose, consistent and meet external and internal requirements. Reporting to the Head of Regulatory, this role will coordinate the implementation of the company quality management system, provide internal training on quality procedures and monitor performance against agreed standards.
- Manage the establishment of the company’s quality procedures to cover its business, laboratory (including interface with GLP and GMP), clinical (GCP) and regulatory activities, including a phased approach based on prioritisation of key initial activities
- Work within a multi-disciplinary team and matrix environment to promote the awareness of quality requirements throughout the company and train staff in quality related activities
- Coordinate the implementation of a fit for purpose company electronic QMS
- Establish, implement and maintain processes, including document control and training, needed for successful performance of the QMS
- Review the performance of the QMS at planned intervals to ensure its continuing suitability, adequacy and effectiveness and propose improvements
- Manage an internal audit programme and propose and implement corrective actions
- Coordinate with purchasing and operational colleagues to establish quality requirements for external suppliers, including audit programme for external third parties
- Ensure company inspection readiness and lead regulatory agency and client inspections
- Provide compliance support to internal staff by providing advice and facilitate escalation of compliance issues through the appropriate route
The successful Quality Manager will have the following qualifications, skills & experiences:
- Be educated to degree level in a scientific discipline (or equivalent)
- Have experience in quality-related activities including the maintenance and monitoring of QMS, preferably including experience in a small / start-up organisation environment
- Be familiar with global standards related to quality e.g. ISO 9001
- Be Familiar with UK and EU regulatory environment for medicinal products, particularly the Good Clinical Practice requirements
- Have experience working with GLP or GMP activities
- Be pragmatic and practical, highly motivated and able to implement workable quality systems and solutions to enable the mission of the company to accelerate the development of cell based therapies in the UK
If successful, you will be joining a group that is passionate about helping to develop a sustainable Cell Therapy Sector in the UK and who wants to play a pivotal role in delivering new therapies to the clinic. In return there is an attractive salary, coupled with excellent benefits and career progression opportunities.
To apply for this position contact Jason Johal on 01438 723 500 or via email on firstname.lastname@example.org Please quote reference ST26838 in all correspondence. Entitlement to work in the EEA is essential.