Associate Director/Director GCP QA (hybrid)
Hobson Prior are currently looking for an Associate Director/Director GCP QA to join a brilliant pharmaceutical organisation on a permanent basis located in the UK with hybrid working available. Our client is focused on creating immuno-oncology therapeutics.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will guide the development, execution and upkeep of QA systems and SOPs for GCP compliance, which involves training, aligned with the organisations' quality management system.
- Handle clinical QA consultants on multifaceted projects.
- Responsible for developing, executing and performing audit agendas, audit reports, and CAPAs for audits both internally and externally.
- The ideal candidate will develop and execute a risk-based audit programme.
- Raise systemic issues and suitable suggestions/solutions to senior management for immediate and long-term resolution.
- Collaborate with internal teams to develop and implement quality plans for clinical studies.
- Support the resolution of compliance concerns at clinical sites, clinical vendors, labs and any other vendors by supplying an assessment of the impact of any deficiencies.
- Recognise and track KPIs for reporting quality metrics.
- Evaluate contracts with clinical vendors and partners to guarantee compliance accountabilities are involved.
- Any other assigned duties.
- Educated to a degree level or corresponding.
- Demonstrable experience within a QA pharmaceutical or biopharmaceutical organisation.
- Familiarity within GCP with the ability to navigate within a quickly developing setting to assist in shaping and evolving the QA division.
- Expertise on the quality content of CTAs/INDs to demonstrate QA experience.
- Comprehension of the regulations such as UK/EU/US, etc.
- Capable of meeting deadlines and managing own time efficiently.
- Communication skills both verbally and in writing towards aa varied audience.
- Works well in a cross-functional project team.
- A high attention to detail.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
€40000 - €50000 per annum
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