Global Quality Auditor

Job description

  Job facts

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

Global Quality and Compliance (GQC) is 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), qualification and development 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.

At Roche you will:

• Perform supplier and/or divisional quality system audits and prepare detailed audit reports

• Continuously improve the effectiveness of existing quality systems and processes by converting supplier and/or quality system related deficiencies into continuous improvements

• Review and approve corrective action plans and actions that result from audits

• Ensure 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; prepare audit trend reports

• Support sites, affiliates, departments and other areas across Roche Diagnostics to ensure sustainable compliance with applicable standards and regulations

** THIS POSITION CAN RESIDE IN INDIANAPOLIS, IN; BRANCHBURG, NJ; TUCSON, AZ; PLEASANTON, CA**

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at .
EEO is the Law

PAY TRANSPARENCY NONDISCRIMINATION PROVISION
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Desired profile

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.

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

Additionally you will have:

• Knowledge of technology and industry quality standards

• Knowledge of product development objectives and strategies

• Profound skills in problem solving, negotiation, decision making, leadership and communication (verbal and written)

• Project management and technical business analysis skills.

• Ability and willingness to travel extensively (incl. internationally) up to 50%

Preferred:

• Auditor certification (ASQ or equivalent)

• 3 years of experience conducting Quality audits in a FDA regulated industry

• CLIA regulation knowledge

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