Clinical QA Manager

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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