Global Quality Auditor (m/f/d)

Job description

·  Job facts

** THIS POSITION CAN RESIDE IN MANNHEIM, PENZBERG OR ROTKREUZ**

Who we are

At Roche, we believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients' lives and we are fearless in both decision and action. We also believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

The Position

As a Global Quality Auditor within Roche Diagnostics Global Compliance and Auditing, you are a results-oriented and technical leader who is passionate about achieving quality objectives regarding Roche Diagnostics Products.

Global Compliance and Auditing is a function within the Strategy and Compliance Office (formerly Global Quality and Compliance), a global, centralized function within Global Quality and Regulatory Affairs that provides results-oriented leadership and technical expertise within Roche Diagnostics in order to achieve sustainable compliance and operational excellence.

The Global Quality Auditor is responsible for the assessment (audits) of new and existing suppliers within Roche Diagnostics, and for performing divisional audits. The global auditor also acts as a consultant in close collaboration with executive management to incorporate and implement appropriate process and business improvements. In this role, you continuously maintain and improve the quality system and achieve quality objectives regarding Roche Diagnostics Products.

What you expected:

·  Plan and perform supplier and/or divisional quality system audits and prepare detailed audit reports (in English)
·  Continuously improve the effectiveness of existing quality systems and processes by supporting the business convert supplier and internal quality system related deficiencies into continuous improvements
·  Review and approve corrective action plans and actions that result from audits
·  Verify the effective execution and/or follow up of CAPAs (Corrective and Preventive Action) and Supplier Corrective Action Requests (SCAR)
·  Verify the closure of corrective actions and preventive actions from divisional audits
·  Determine the statistical sampling of documents and records to be reviewed during audits
·  Support sites, affiliates, departments and other areas across Roche Diagnostics to ensure sustainable compliance with applicable standards and regulations

Who you are:

To be successful in this role you will have at a minimum a Bachelor's degree in science, engineering or technical discipline and proven 5 years of Quality Auditing experience in FDA or related industry, or 9 years of related Auditing experience. Degree preferred.

Additionally, you will have:

·  Knowledge of technology and current industry quality standards
·  Knowledge of product development objectives and strategies
·  Profound skills in problem solving, negotiation, decision making, leadership and effective communication (verbal and written)
·  Ability and willingness to travel extensively (incl. internationally) up to 50%

Preferred:

·  Auditor certification (ASQ or equivalent)
·  No less than 3 years of experience conducting Quality audits in a FDA regulated industry (medical devices, IVDs or pharmaceutical industry)
·  Leadership competencies, empowering and inspiring leadership style
·  CLIA regulation knowledge
·  Excellent english and german

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

We are looking forward to receiving your application!

Application documents:

For complete applications documents, we kindly ask you to send an updated CV. Further documents are requested when required. Please note before you post your application, that it is not possible to add documents afterwards.

Please contact us if you have any questions!

Do you need further assistance? Our Talent Acquisition Team is available for you by phone from monday to friday from 9-12 am and from 1-4 pm by phone: 0621-759 68642. We are pleased to respond to your inquiries.

Roche is an equal opportunity employer.
Quality, Quality > Quality Validation

·  Who we are

With more than 12,000 employees Roche Diagnostics GmbH (RDG) represents the third largest site within Roche. Apart from the two sales organizations in Germany (Roche Pharma AG and Roche Diagnostics Deutschland) RDG is focused on the operative business. At the two sites in Mannheim and Penzberg new diagnostic tests and pharmaceutical active ingredients are developed and produced for the global market.

Roche is an equal opportunity employer.

Desired profile

Who you are:

To be successful in this role you will have at a minimum a Bachelor's degree in science, engineering or technical discipline and proven 5 years of Quality Auditing experience in FDA or related industry, or 9 years of related Auditing experience. Degree preferred.

Additionally, you will have:

·  Knowledge of technology and current industry quality standards
·  Knowledge of product development objectives and strategies
·  Profound skills in problem solving, negotiation, decision making, leadership and effective communication (verbal and written)
·  Ability and willingness to travel extensively (incl. internationally) up to 50%

Preferred:

·  Auditor certification (ASQ or equivalent)
·  No less than 3 years of experience conducting Quality audits in a FDA regulated industry (medical devices, IVDs or pharmaceutical industry)
·  Leadership competencies, empowering and inspiring leadership style
·  CLIA regulation knowledge
·  Excellent english and german

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

We are looking forward to receiving your application!

Application documents:

For complete applications documents, we kindly ask you to send an updated CV. Further documents are requested when required. Please note before you post your application, that it is not possible to add documents afterwards.

Please contact us if you have any questions!

Do you need further assistance? Our Talent Acquisition Team is available for you by phone from monday to friday from 9-12 am and from 1-4 pm by phone: 0621-759 68642. We are pleased to respond to your inquiries.

Roche is an equal opportunity employer.
Quality, Quality > Quality Validation

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