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Regional Audit Compliance Manager

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Safety, Quality & Compliance
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A fantastic opportunity is available for a Regional Audit Compliance Manager to join our Safety, Quality, and Compliance team.

 

To act as an independent assurer of quality and compliance throughout RB operations (in the applicable region), including ensuring 100% compliance with Regulatory requirements and minimum RB  standards, reviewing and maintaining sites’ compliance with ISO, ICH,  EMA, FDA and ANVISA  standards as applicable. Provide coaching and mentoring to enhance organizational compliance and defining and adoption of best practices.

 

 

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 Compliance Director and will continually feed into the responsible Senior Leadership teams (GSLT, RDLT, GQLT, and SQCLT).

 

 

 

Key Responsibilities


 

  • Conduct audits of Regulatory, 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


 

Planning


 

  • Plan an audit schedule that ensures 100% compliance with minimum quality and compliance standards on a risk based approach
  • Support audits outside of region but with area of expertise
  • Maintaining awareness of regulatory and Corporate related developments for quality and compliance which may impact compliance
  • Coordinate planning activities with other compliance functions (e.g. Internal Audit) to maximise efficiency and effectiveness of group audit programmes


 

 


 

Implementation and Operation


 

  • Conduct in depth audits at of Manufacturing, R&D, Distribution Centres and Commercial sites within the region.   The audits will focus on RB standards, and applicable regulatory requirements.
  • Develop and maintain detailed action plans and dashboards for each site to ensure that they achieve 100% compliance against all minimum requirements
  • Prioritise and conduct follow up audits for all sites to ensure close out of actions
  • Outline management systems weaknesses within organization
  • Take immediate action on site, even if this means stopping operations, if significant non-compliances are identified.
  • Provide detailed reports of audits and conditions of site to Global Audits Compliance Director.
  • Assess competence and culture on site to ensure no gaps in knowledge from Leadership and Quality and Compliance teams and recommend improvements
  • Provide regular progress updates to the SQC team and senior business leaders as required


 

 


 

Training and Education


 

  • Coach Supervisors and Regulatory and Q&C team on requirements of Minimum standards during audit approach to help achieve consistent standards across all sites


 

Interface With Other Functions


 

  • Provide verbal & written updates to senior leadership teams (e.g. GSLT) when required
  • Engage with SVP and Regional Manufacturing Directors as required to provide information, updates and to address escalated issues
  • Ensure consistent approach is taken globally by working with other Regional Q&C Assurance Managers
  • Work with Regional Q&C Managers to discuss findings, agree prioritisation, develop consistency, co-develop action plans, benchmark and improve oversight of region
  • Engage with other audit functions, as applicable, to ensure consistent, efficient and effective global audit programmes

Is this You?


 

  • Hold Diploma in Biology, Chemistry or another scientific related field  

  • 5-10 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

  • Experience in coaching, development and management of teams
  • Demonstrated ability to work across functions, businesses and internationally  


 

  • MUST be willing to stop operations if serious quality and compliance risk identified

  • Experience in working with Senior Management
  • Be confident to support all decisions they make and robustly deal with challenge from all levels of the business.

  • Be persistent and undeterred on encountering obstacles and tracking work through to completion.

  • Have clear and concise communications skills, both written and verbal, requiring a good level of English language, with the ability to adapt communications to various audiences

  • Be highly organised, in terms of both personal approach and reporting, to ensure all actions are suitable, practical, compliant and achievable

  • Be self-motivated, proactive and self-sufficient and comfortable working independently

  • Have and express a positive attitude to quality and compliane in all activities while auditing and not accept any poor practices or behaviours.

  • Ability to build and maintain knowledge across RB.
  • Excellent attention to detail but can also put thinking into perspective (see the bigger picture).

  • Be willing to travel up to 70%


 

Why RB?
  • Fast paced. Tired of having to jump through endless hoops to get things done? Not here. We move fast and deliver.

  • Growth. Frustrated by the lack of growth opportunities in your current company? Not here! RB takes pride in the development and continued growth of our employees through steady rotations and promotions. 

  • Autonomy. RB empowers you to OWN what you do.  

  • Iconic Global Brands. http://bit.ly/RBNABrands Take a look. You'll be surprised at how many you already have in your home.

  • Feel good about the company you work for! RB is committed to making the world a better place through betterbusiness. http://bit.ly/rbsustainability

  • Passport Stamps. Does working Internationally interest you? Perform well and Global doors can open for you at RB.

  • Work with smart people. We have a talented workforce that believes in sharing ideas to help each other, and the company succeed. 

  • Vacation. We offer 4 weeks’ vacation, 9 core Holidays and 4 floating days.

  • 16 weeks paid Maternity leave. 
  • Competitive base salaries and bonuses. 
  • Tuition reimbursement.
 

 

 

 








In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organisation. 
 

Apply Now for a chance to really change the game!


 

 

 
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

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