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Job Details

Senior Manager - Medical Affairs Quality Assurance

Company: RBW Consulting
Location:
Reference: AC/SMQAMA/PAR
Closing Date: 27 Nov 17
Type: Permanent
Salary (£): Competitive
Benefits: EXCELLENT

Job Summary:

Senior Manager - Medical Affairs Quality Assurance - Globally established Pharmaceutical Brand

Requirements:

My client a market leader within the Life-Science industries is now looking to identify their newest member of the group for a position which is very unique within the market. At present, we are currently looking to speak with candidates who have dual skills ideally in the field of Quality and Medical Affairs/Clinical Affairs to assume a new role within of ‘Senior Manager - Medical Affairs Quality Assurance’ based out of Paris.

Key Responsibilities

  • Key in the development and maintenance of a quality system designed specifically for Medical Affairs Compliance
  • Work in close collaboration with CPM’s to ensure good GCP is in line with all necessary regulatory guidelines
  • Key participant to project meetings which relate to Quality
  • Contribute to vendor QA meetings ensuring any key aspects are implemented
  • Create SOP’s for Medical Affairs activities and ensure documents are up to date
  • Develop Quality documentation related activities
  • Evaluate and monitor report status
  • Train and guide key users of the Quality documentation processes
  • Full management of the CAPA process for Clinical and Medical affairs matters
  • Accurately record and report CAPA status and manage delivery/timelines
  • Full Deviations and serious breach management
  • Perform Risk assessments
  • Ensure Continuous improvements methods are maintained
  • Support audit activities
  • Provide key responses and address questions following the audit reviews
  • Key contribution to training activities related to the specific area
  • Create quality objectives and goals applicable to the Medical affairs area
  • Liaise with Global Quality teams

Skills needed

  • At least 7 years of total career experience working within the Life-Science industry
  • At least 4 years’ experience working within Medical affairs ideally with exposure to QA or with a distinct understanding 
  • Fluent in English and ideally French
  • Thorough understanding of Medical Affairs aspects and procedures 
  • Previous audit and CAPA experience would be preferred
  • Ideally skilled within a global environment
  • Excellent interpersonal and communication skills
  • Can work office based in Paris

At RBW Consulting Ltd, every one of our consultants has the benefit of multiple years’ experience in helping Pharmaceutical & Medical Device Professionals find the right career step for their current and future aspirations. With unrivalled industry knowledge and network in Biotech’s, Pharmaceutical and Medical Device Companies throughout the UK, Switzerland and Europe, we would be delighted to speak with you about the role you are looking for.

For a confidential chat, please contact Antony Clark at RBW Consulting on +44 (0)1293 584300 or email antony.clark@rbwconsulting.com for full details.

 

Apply for this job: Senior Manager - Medical Affairs Quality Assurance

Contact Information:

Address:  Head Office
Origin Two 106 High Street, Crawley RH10 1BF
RH10 1BF
England
Tel:  01293 584 300
Fax:  01293 534 133
Website:  Visit Our Web Site

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