Associate Director, Clinical Quality Assurance (GCP)
Full-time, Permanent role
Hertfordshire, UK - Hybrid
An exciting role to join a mid-sized Pharmaceutical business with an extensive portfolio across the Oncology, Neurology and Pain therapy areas. The Associate Director, GCP Quality Assurance, works within the Global Clinical Quality Assurance (CQA) team to conduct GCP compliance activities. The position will manage cross-functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams on assigned trials. This is a high-visibility position with great impact potential.
What are we looking for?
* Educated to a Bachelor’s degree in an associated functional discipline, advanced degree preferred
* Demonstrated experience in Clinical research/operations/data management or related area.
* Demonstrated experience in Clinical Quality Assurance
* Health Authority inspection management
Main duties/responsibilities
* Representing CQA at internal, cross functional team meetings
* Supporting the training and development of CQA colleagues
* Proactively provide GCP QA support for clinical development activities to protect patient safety & well being, maintain data integrity, and support operational excellence
* Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and Vendor/System audits
* Acting as CQA Lead for clinical studies, drafting and managing Audit Plans and Audit reports
* Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
* Manage health authority inspections preparation activities and provide leadership and oversight during inspections
* Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs)
* Compile and analyze audit metrics to communicate trends to business groups
* Conduct GCP training sessions for business groups
Working relationships:
* Internal partners including:
* QA UK colleagues and management
* International CQA colleagues and management
* Local and global clinical operations,and R&D stakeholders
* External partners including:
* Industry forums and Global Quality Assurance peers
* Quality and operational representatives of strategic partner organisations (e.g. CROs)
For more information, please reach out to me at lucy.kirkaldy@cpl.com