QA Compliance Manager
Hobson Prior are looking for a QA Compliance Manager to join a leading pharmaceutical organisation in London to develop and ensure procedures and systems within the organisation are compliant to applicable US and EU GxP and other national regulations where we conduct clinical trials.
- Ensure the compliance of the organisation to applicable EU and US GxP regulations by ensuring effective monitoring systems are developed, maintained and communicated.
- Monitor new European and US legislation or changes in regulations that may affect the company's compliance, necessitating changes to company QMS documents in a timely way to ensure compliance and inspection readiness.
- In co-operation with the Head of Regulatory Affairs and Head of Quality Assurance, establish and maintain annual training plans for the EU/US Drug Development Division and be responsible for the implementation and delivery (in-house or outsourced trainers) of the training plans.
- Assistance in managing the company's Quality Management System ensuring completeness and accuracy.
- Keep up to date with current European and US best practices and changes in legislation that may affect the way we conduct clinical trials and the data it generates and manage the development/coordination of appropriate internal training requirements
- Deliver and coordinate the delivery of high-quality training materials to internal personnel in the management of key GCP and other GxP topics including how to reduce audit findings, serious breaches, urgent safety measures, risk assessments.
- Manage QMS training to ensure all staff are compliant with current regulations and provide regular status updates to the Head of QA, DDD management and the MD.
- Act as a process expert regarding maintenance of the QMS (e.g. SOP review steps).
- Excellent administration skills and attention to detail.
- Strong written and spoken English.
- Excellent communication skills (verbal and written), organisation and time management skills.
- Ideally a MSc (or equivalent) in life sciences, nursing or a combination of education (BSc) and practical experience.
- Solid demonstrable GCP Compliance experience gained within a global contract research organisation, pharmaceutical or Biotechnology Company, particularly with experience working in a Japanese organisation would be preferred.
- Demonstrable QA experience and ideally further compliance experience in the industry sector and/or corporate compliance.
- Solid experience of producing and delivering training programmes and workshops. Excellent presentation skills are essential.
- Proficient computer skills in Word, Excel, PowerPoint, email and Internet.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.
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