Hobson Prior are currently working alongside a fantastic biotech establishment who have an opening for a Good Clinical Practice Compliance Manager to join their team on a contract basis. Our client is focused on converting ground-breaking concepts and findings into remedies for people who suffer from serious diseases.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will improve R&D procedures through inputting knowledge in recognising suitable CAPAs.
• Facilitate accomplishment of CAPAs through CAPA statis documents in a timely manner.
• You will recognise CAPA trends.
• Assist in GCF level 6 investigation lead in RCA and efficiency verification actions of CAPAs.
• Gather and verify goal evidence for examination and audit driven CAPAs.
• Manage GCP compliance metrics for allocated projects and fields of focus.
• The ideal candidate will enter and update records in RDCS based on examination and allowance meetings and tracking to closure.
• Assist in the R&D compliance of governance authorities within the clinical development, pharmacovigilance and/or research field.
• Implement exception management procedures, tools and strategies which involves RCA.
• Any other assigned duties.

Requirements:

• Educated to a degree level in a suitable field or similar.
• At least 4 years of experience in a biopharmaceutical establishment.
• At least 2 years of experience with GCP compliance.
• International GCP guidelines knowledge.
• Know-how of regulatory authority inspection procedures.
• Know-how of GCP procedures and operations within a biopharmaceutical organisation.
• Comprehension of audit/compliance program design.
• Ideal to possess a GCP Quality Assurance Qualification/Certification.
• Capable of contributing to process development projects.
• Knowledge/business insight and subject matter expertise.
• Interpretation of the company objectives and competitor techniques.
• Previous involvement in assisting regulatory authority inspections of GCP actions such as clinical research, pharmacovigilance, etc.
• Comprehension of company business priorities, tactics and direction.
• Acquaintance with exception management which involves RCA within a GCP field.
• Know-how of fields acknowledged by the GCP compliance function.
• R&D function and business standards knowledge.
• Able to implement analytical abilities.
• Capable of handling various assignment simultaneously.

Apply now:

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.