Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Quality Manager - QA Compliance - GCP

Company: Barrington James Clinical
Location: Cambridge - Home Based Flex
Reference: em-qaman
Closing Date: 05 Jan 19
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits: Competitive

Job Summary:

Quality Manager - QA Compliance - GCP

Requirements:

Responsibilities:

  • To provide support and participate in internal and external, and other regulatory agency inspections (FDA, EMA, etc)
  • Take part in the GCP, GCLP and GLP Compliance Programmes
  • To lead and manage the CAPAs, Deviations, Audits and Vendor Quality Management Programs
  • To lead, Develop and manage the Compliance staff and provide coaching and mentoring on Quality Management Systems
  • To participate in internal and external audits, and support vendor quality management activities
  • To conduct compliance risk assessments, trend analysis and provide recommendations for compliant business activities
  • To supply feedback to the HCQA/DOQ and other senior management on any trends and serious quality issues or non-compliances that are detected by CQA staff whilst carrying out duties for GCP, GCLP, GCLP and GVP activities
  • To liaise with auditors to ensure that the CAPAs resulting from audits associated with the assigned programmes and studies are allocated a CQA CAPA owner and closed out appropriately and in a timely manner
  • To author, reviews and/or authorise Standard Operating Procedures (SOPs)
  • Member of the Quality Leadership Team.

 

Experience:

  • A Batchelor’s degree or equivalent in scientific discipline
  • Extensive experience in clinical/pre-clinical research in a healthcare company, with demonstrated knowledge and experience of auditing/inspection techniques, including study specific, vendors, internal process/system, pharmacovigilance activities, regulatory submissions, and documentation audits, as well as experience of related quality assurance principles applicable to clinical trials
  • Demonstrates a “can do” approach
  • Excellent attention to detail and the ability to identify the root cause of problems
  • Competency in use of electronic systems for management and tracking of audits, audit reports and CAPAs
  • Previous people leadership experience preferred
  • Previous experience working with FDA (CBER) and participating in regulatory agency inspections

 

Apply for this job: Quality Manager - QA Compliance - GCP

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.