170 days ago on roche.com

Global GMP Compliance Auditor Expert

Roche AG

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Global GMP Compliance Auditor Expert

Global GMP Compliance Auditor Expert

Switzerland, Basel-Town, Basel

Our GMP Compliance Audit group supports Roche's right to operate by enabling compliance sustainability through expert audit practices, GMP consultation and data analysis.

We are a highly respected GMP Compliance Audit organization. We work in partnership across the Roche global network to meet our patients' needs by enabling sustainable compliance. We are committed to continuously improving our effectiveness and efficiency to enhance the contribution to Roche's success.

In this role you are part of the Compliance Audit EMEA group and you directly report to the Head of the Region. You ensure effective GMP Compliance Audits of internal and external sites with significant quality and compliance relevance.

 

We offer the following main responsibilities:

 

  • Identify and report critical and major Quality and Compliance risks and gaps while leading complex and demanding audit activities
  • Conduct due-diligence and qualification audits of potential new partners, contractors and suppliers and conduct effective “for cause” (directed) audits
  • Provide effective support during regulatory inspections as requested by Quality Assurance Operations of Roche sites
  • Support departmental and cross-regional projects within Global Compliance Audit to improve effectiveness and efficiency and to improve team development

We highly value your expertise. Indeed, you act as a mentor for junior auditors to increase their auditing skills and lead the global Auditor Qualification Program.

We also expect you to provide advice and support to project teams for new business/products, to ensure the approach and direction of the Corrective Action Preventive Action plan and general quality improvements required are focused in the direction of the Roche business strategy and on achieving a successful regulatory outcome.

In parallel, you provide “specialist” advice, both internally within our team and in response to external requests.

  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

    You have a Graduate degree in Chemistry, Pharmacy, Microbiology, Engineering or similar. You already possess Audit experience in the (bio)pharmaceutical industry, alongside a minimum of 10 years of broad experience in this field or another related regulated industry. Prior experience as a Regulator would be helpful.

     

    You bring the following qualifications:

     

    • Valid operational experience includes quality management, QA operations, production, development or QC operations, or other relevant experience
    • Confirmed experience in compliance related remediation, working knowledge of quality management concepts, risk management techniques
    • Excellent oral and written English communication skills. Second language is helpful
    • You are able to travel 30-50%

  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Quality & Compliance
    • Subfunction Other Quality
    • Schedule Full-time
    • Job level Individual Contributor
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Posted since 2017/11/16
    • Job-ID 2537825407
  • Get in touch
    Marion Troian +41 61 68 85431

    Work location: Basel