Clinical Quality Manager
Permanent – UK field role
Remote role with some travel for work (up to 15% of the time)
£60k – £65k + up to 20% bonus
- Reporting to the Head of Quality, the individual will lead the Clinical Quality Assurance (CQA) function and processes across the companies group and external network. This will include responsibility for maintaining and developing the CQA and compliance processes and culture.
- Leading compliance with internal, national, and international regulations in every aspect of clinical development.
- To maintain and develop the clinical elements of the company’s QMS. This will include critical review of existing procedures and documentation and where necessary creation of new processes in collaboration with the wider Clinical team.
- Guide, develop and maintain QA and control systems to ensure clinical trial data integrity.
- Provide CQA compliance support throughout the clinical development process, from design of the protocol to the final clinical study report, to ensure compliance with applicable governmental regulations as well as company policies and procedures.
- Coordinate audit plans (internal and trial specific) and lead the auditing of clinical trial activities (vendors and investigator sites) to ensure compliance with GCP, applicable regulations and guidelines. To include coordination of audits conducted by contract auditors.
WHAT YOU WILL NEED…
- Educated to degree level or equivalent in Life Sciences, Biochemistry, Chemistry, Pharmacy or with an applicable medical qualification.
- Significant industry experience in GCP and Clinical QA.
- Experience in GCP auditing of clinical vendors, CROs and investigator sites.
- Experience in preparing for and managing inspections by Governmental Authorities e.g., MHRA, FDA.
- Detailed knowledge of QMS and global GCP requirements.
- Experienced in delivering GCP education, training, and improvement.
- Experience in supporting clinical supply e.g., clinical labelling is desirable.
- Motivated, self-starter with the ability to coordinate the CQA function with direct, motivate and lead team members by example and from afar.
- Financial awareness with budgeting ability.
- Willing to travel within UK, EU and internationally for up to 15% of time.
- Great Pension Scheme
- Private Medical Insurance
- Discretionary Bonus Plan
- Paid Maternity and Paternity Leave
- Some travel with work (up to 15% of the time)