Clinical QA Manager job in London, England

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Job type: Permanent

Discipline: Good Clinical Practice (GCP)

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Clinical QA Manager to join a biotech organisation. This role is on a permanent basis and is located in London.

Responsibilities:

Assist the clinical operation team with preparing, arranging and managing regulatory agency inspections.
Evaluate and update the company's SOPs, recognising the requirement for new SOPs as well as evolve new quality SOPs.
You will develop and measure GCP quality metrics to drive constant quality standards throughout the business.
Possible serve as a clinical development quality lead for a specific project or as back-up if necessary.
Train and business shareholders by offering guidance, knowledgeable advice, assistance and management for translating the quality method into operations.
Partake in ideal CRO/Vendor selection and qualification procedure, examine pertinent CROs process throughout selection procedure.
Uphold databases for investigator site audit observations and CAPAs.
The ideal candidate will track, evaluate, approve and examine the sufficiency of CAPAs.
Work alongside the compliance QA team on tracking vendor audits and CAPA tracking for external clinical vendors.
Other duties may be assigned to this role.

Key Skills and Requirements:

Demonstrable experience with clinical quality assurance with familiarity in clinical auditing/oversight in the regulatory compliance setting or a corresponding mixture of experience and education.
Follows ethical and GCP with the ability to work well in a team as well as independently.
Competency in ICH GCP, FDA and suitable CFRs guidance documents, systems procedures and processes which involves working within a QA role assisting on regulations compliance.
Comprehension of suitable US and ICH GCP guidelines/regulations to enable the comprehension and impact of discoveries of both internal and external audits.
Stay updated on changes to current GCP/GLP/GCLP guidelines, regulations, safety reporting which involves FDA, EU, and any other regulatory bodies.
Familiarity within clinical operations and managing necessary documents.
Prior involvement in performing PV, GLP and/or GMP audits would be beneficial.
Interpersonal, deliberation and communication skills both verbally and in writing.
Able to resolve issues.
Capable of upholding company ethical standards.
An organised individual with the ability to work on various projects simultaneously with competitive timelines.
Capable of handling multifaceted projects.
Willing to travel for business needs which might involve global travel.
Computer literacy.
A high attention to detail.
Works well in a team.

If you are having difficulty in applying or if you have any questions, please contact Ieuan Phillips at +44 203 846 0643.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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