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.
- 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.