Healthcare Compliance Quality Manager

Highly Competitive
  1. Contract
  2. Good Manufacturing Practice (GMP)
  3. United Kingdom
Hayes, Middlesex
Posting date: 08 Nov 2018
QA.CM.20291_1541689442

A leading biotechnology company is seeking a Healthcare Compliance Quality Manager to join their team in Hayes, UK on a contract basis.

Job Role:

  • To provide oversight of and guidance on Company processes related to the ABPI and IPHA Codes of Practice, supporting affiliate healthcare compliance (HCC) activities with particular focus on supporting the Affiliate Quality Management System (QMS), and identifying opportunities for continuous improvement.

Job Responsibilities:

  • Develop and deploy a Continuous Process Improvement Plan: Define, manage and monitor Code of Practice-related Corrective and Preventative Actions (CAPA), Investigating non-compliance incidents and follow up on related CAPA, ensuring accurate documentation is maintained.
  • Support process owners in developing, managing and closing HCC-related Change Controls and in collaboration with the Quality team
  • First-line point of contact for Code of Practice-related
  • Quality process questions for both the affiliate and above-country colleagues.
  • Escalate queries where required and work with Regulatory Quality and Compliance team, Final Signatories and Code of Practice Forum (as appropriate) to ensure timely responses/required solutions are delivered to internal stakeholders
  • Working with Process Owners, develop/maintain Code of Practice-related SOPs, in collaboration with the relevant internal stakeholders
  • To monitor legislation, guidelines and the national regulatory environment to maintain company intelligence and awareness of compliance and best practice within the affiliate.
  • Provide support for internal /external audits/inspections for the UK/Ireland Affiliate in relation to Code of Practice activities in collaboration with the Quality team
  • Report relevant metrics to affiliate management team and other relevant internal stakeholders Internal affiliate Development (Culture)
  • Work with the Quality team to continuously educate the affiliate on the importance of quality management and facilitate implementation of best practices
  • In coordination with the Quality and Compliance Training Manager ensure appropriate training is delivered and recorded for relevant personnel in the affiliate and relevant third parties.

Education, Skills and Experience:

  • Life science/pharmacy degree
  • A professional qualification in Quality &/or auditing would be advantageous
  • Established knowledge of the quality management principles and systems (QMS)
  • Experience of third party risk management processes
  • Experience and knowledge of the ABPI and IPHA Codes of Practice.
  • Experience of hosting and conducting audits and internal quality/compliance reviews

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-CM3

close