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Vacancy details
Vacancy description:
Job Code:
J407600
Job Title:
Senior Manager Clinical QA Quality Assurance
Job Category:
Regulatory And Drug Safety
Contract:
Locum/Temporary
Discipline:
QA, Drug Safety, Pharmacovigilance, Regulatory Affairs, Director
Country:
United Kingdom
Location:
Bedfordshire, Buckinghamshire, Cambridgeshire, Essex, Hertfordshire, London - Central, London - North
Min experience:
N/A
Annual salary:
45000 £
Apply by:
16 May 2008
Senior Manager Clinical QA
Our client a TOP GLOBAL Pharmaceutical company are now looking to recruit again due to expansion; as a large Pharmaceutical company our client provides excellent career progression with exciting and diverse products. An excellent company to take the next step up your career ladder!
Main purpose of the job:
To support the Associate Director, Clinical QA in the management and implementation of Clinical QA responsibilities related to all clinical trial procedures including internal systems, external providers and computer systems validation.
Main duties/responsibilities:
The tasks of the Senior Manager, Clinical QA will include, but not be limited to, the following activities:
•Line manager to reporting team, including responsibility for resource allocation, training and mentoring, goal setting and performance appraisals.
•Represent CQA in the absence of the Associate Director, CQA or as delegated.
•To plan, prepare, perform and report clinical audits in all areas of clinical research including investigator sites, CROs, laboratories, Phase I units and computer systems to ensure trials conform to applicable regulations, ICH-GCP, and the relevant Standard Operating Procedures (SOPs). This includes responsibilities for planning and managing global audit programs, where required, and follow-up to satisfactory resolution of quality issues.
•To conduct internal audits to ensure compliance of internal procedures to current regulatory requirements and adherence of personnel to internal procedures.
•To provide guidance and/or training to company personnel on GCP/SOP/QA related matters.
•Maintain and develop knowledge of international regulations and guidelines.
•Contribute to CQA problem solving, including identifying issues, and providing solutions.
•Assist in the development of company CQA SOPs and associated documents.
•Act as CQA representative on IPTs and/or study teams and other projects, as required.
Qualifications and education required:
Educated to degree level in relevant subject (e.g. Life Science, Science, Pharmacy).
Experience required:
•Relevant years of clinical research to at least Senior CRA or equivalent level
•Relevant years experience in Clinical QA.
•Comprehensive knowledge of ICH GCP, in-depth knowledge EU regulatory standards for the conduct of clinical trials and understanding of US FDA requirements.
Keywords:
Senior Manager CQA Clinical QA Clinical Quality Assurance London Middlesex Hertfordshire Buckinghamshire Berkshire Essex South South East Home Counties
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