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REGIONAL AUDIT COMPLIANCE MANAGER

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JOB SUMMARY

The role will be part of the Compliance team and part of the broader global SQC team. This role will lead quality assurance audits, inspections (internal and external) and monitor procedures against Standard Operation Procedures (SOPS), methods, protocols and relevant regulations/ guidelines.  As such this role will have visibility and access to the highest levels of the organisation.  The role will report directly to the Global Head Quality Audits AMESA, NoA & ASEAN and will continually feed into the responsible Senior Leadership teams (GSLT, RDLT, GQLT, and SQCLT).

 

Key Roles

  • Conduct audits of Manufacturing, R&D, Distribution Centres and Commercial sites within their region to ensure consistent compliance against RB minimum quality and compliance standards and applicable regulatory requirements.
  • Generate detailed audit reports specifying identified gap, areas for improvement and recommendations.
  • To conduct follow up visits, as required, to sites identified as High Risk
  • To work with Regional Quality and Compliance (Q&C) Managers to ensure all actions are fully closed out in line with expectations
  • Provide coaching and mentoring to enhance organizational compliance
  • Define and deploy best practices
  • To escalate issues / concerns to Regional Directors, SVPs, GQLT and the GSLT

 

Is this you? 

  • Degree in Pharmacy, Chemistry or other scientific related field  
  • 8-10 years’ experience working with drug, medical device, cosmetics, REACh compliance in Pharmaceutical and/ or Consumer Health Industry.
  • Experience specifically experience in quality systems, regulatory affairs or regulatory compliance preferred
  • 3 years’ experience conducting quality and compliance audits
  • Good understanding of Quality and compliance regulations related to a manufacturing R&D, Distribution Centres and Commercial sites site in one or more countries.
  • Experience working with one or more of the following regulatory Agencies FDA, EPA  MHRA, ANVISA, CFDA, EMA etc
Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Job Segment: Medical, Pharmacy, Medical Device, Healthcare

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