Quality & Regulatory Compliance Audit & Inspection Team Lead (USA / APAC)

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The Position

Who We Are

At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow., and access to medical innovations for all. We do this today to build a better tomorrow.

Role Purpose

As the Global Q&R Compliance Sub Chapter Lead Audit & Inspection Readiness US /APAC you will be a member of the Global Q&R Compliance Audit & Inspection Readiness Team as well as of the extended Global Q&R Compliance Leadership Team.

In this position, you will be the leading figure and key point of contact for Roche Diagnostics’ capabilities in development/implementation of the audit and inspection readiness process across the Roche Diagnostics organization including the affiliates. You will improve the sub chapter’s overarching expertise based on current and upcoming needs to deliver on network priorities.
 

You will be responsible to excel in developing the capabilities of Sub Chapter members specialized in Audits/Inspection Readiness including their skills. As a line manager of the Sub Chapter members, you will be responsible for designing and optimizing Sub Chapter members’ personal professional journey and coaching your direct reports.
 

You will partner primarily with the Function Head, the Network Leads, the Chapter and Sub Chapter Leads within the Global Q&R Compliance Team as well as with the relevant stakeholders within Roche Diagnostic. These interactions are intended to support bringing the right capabilities and expertise to the efforts, squads and COPs to deliver across Networks’ priorities (who organize around business value). You will play a key role in crafting and implementing key aspects of the Global Q&R Compliance Team’s mid- to long-term strategy and ultimately contribute to the overall Roche Diagnostics Vision.
 

You will perform internal and supplier (vendor) audits of the quality system and associated processes globally – including audit preparation, conducting audits, writing detailed audit reports, communicating findings to business and other stakeholders, and audit follow-up.

You will be responsible to...

1. Ensure that Roche Diagnostics’ capabilities in Global Q&R Compliance thrive:

• Leverage a consolidated view of the Sub Chapter’s capabilities to represent the most senior level of specialized expertise in audits/inspection readiness towards Business/Global Functions and Regions/Affiliates of Roche Diagnostics.

• Define the short and long term capability needs for the Sub Chapter to deliver on the Function’s and Network’s strategy, and execute on it

• Establish and further develop best practices and thought leadership for all aspects pertaining to Audits/Inspection Readiness exemplify the principle of proactive and continuous improvement

2. Be an active coach and mentor to members of the Sub Chapter to help them grow and progress in their career Nurture and develop an empowered, knowledgeable, effective and efficient group of experienced and high experienced subject matter experts (SMEs) within the Sub Chapter with the capabilities to support Roche Diagnostics’ efforts with best-in-class expertise

• Nurture and develop an empowered, knowledgeable, effective and efficient group of experienced and high experienced subject matter experts (SMEs) within the Sub Chapter with the capabilities to support Roche Diagnostics’ efforts with best-in-class expertise

• Ensure that personal professional development is a priority in assignments of Chapter members and spread awareness for this

• As a line manager of Sub Chapter members, you will be responsible for designing and optimizing Chapter members’ personal professional journey and coaching your direct reports, enabling the fluidity of resources intended by our New Ways of Working. You also will be responsible for performance and compensation management, job description, regular feedback, resource planning &